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Sun E, Littenberg G. Reimbursement and Regulatory Landscape for Artificial Intelligence in Medical Technology. Gastrointest Endosc Clin N Am 2025; 35:469-484. [PMID: 40021242 DOI: 10.1016/j.giec.2024.12.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/03/2025]
Abstract
Integration of artificial intelligence (AI) into medical devices and services promises significant improvements in the diagnosis and treatment of disease. This article reviews current payment pathways for AI medical technology and the regulatory issues affecting both technology development and practical use by physicians; it discusses the need for data privacy, security, and transparency in AI. The Food and Drug Administration's regulations aim to balance safety, efficacy, and innovation encouraging research and collaboration with stakeholders. Effective regulation and reimbursement strategies are essential for the successful adoption of AI in health care, ensuring improved patient care and trust in these technologies.
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Affiliation(s)
- Edward Sun
- Division of Gastroenterology, Peconic Bay Medical Center - Northwell Health, 1 Heroes Way, Riverhead, NY 11901, USA.
| | - Glenn Littenberg
- Genesis Healthcare Partners, Unio Specialty Care, 630 South Raymond Avenue, Suite 240, Pasadena, CA 91105, USA
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Avram MF, Lupa N, Koukoulas D, Lazăr DC, Mariș MI, Murariu MS, Olariu S. Random forests algorithm using basic medical data for predicting the presence of colonic polyps. Front Surg 2025; 12:1523684. [PMID: 40099225 PMCID: PMC11911476 DOI: 10.3389/fsurg.2025.1523684] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2024] [Accepted: 02/10/2025] [Indexed: 03/19/2025] Open
Abstract
Background Colorectal cancer is considered to be triggered by the malignant transformation of colorectal polyps. Early diagnosis and excision of colorectal polyps has been found to lower the mortality and morbidity associated with colorectal cancer. Objective The aim of this study is to offer a predictive model for the presence of colorectal polyps based on Random Forests machine learning algorithm, using basic patient information and common laboratory test results. Materials and methods 164 patients were included in the study. The following data was collected: sex, residence, age, diabetes mellitus, body mass index, fasting blood glucose levels, hemoglobin, platelets, total, LDL and HLD cholesterol, triglycerides, serum glutamic-oxaloacetic transaminase, chronic gastritis, presence of colonic polyps at colonoscopy. 80% of patients were included in the training set for creating a Random forests algorithm, 20% were in the test set. External validation was performed on data from 42 patients. The performance of the Random Forests was compared with the performance of a generalized linear model (GLM) and support vector machine (SVM) built and tested on the same datasets. Results The Random Forest prediction model gave an AUC of 0.820 on the test set. The top five variables in order of importance were: body mass index, platelets, hemoglobin, triglycerides, glutamic-oxaloacetic transaminase. For external validation, the AUC was 0.79. GLM performance in internal validation was an AUC of 0.788, while for external validation AUC-0.65. For SVN, the AUC - 0.785 for internal validation and 0.685 for the external validation dataset. Conclusions A random forest prediction model was developed using patient's demographic data, medical history and common blood tests results. This algorithm can foresee, with good predictive power, the presence of colonic polyps.
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Affiliation(s)
- Mihaela-Flavia Avram
- Department of Surgery X, 1st Surgery Discipline, "Victor Babeș" University of Medicine and Pharmacy Timișoara, Timisoara, Romania
- Abdominal Surgery and Phlebology Research Center, "Victor Babes" University of Medicine and Pharmacy, Timisoara, Romania
| | - Nicolae Lupa
- Department of Mathematics, "Politehnica" University of Timişoara, Timisoara, Romania
| | - Dimitrios Koukoulas
- Department of Gastroenterology, Municipal Hospital "Dr. Teodor Andrei", Lugoj, Romania
| | - Daniela-Cornelia Lazăr
- Department V of Internal Medicine I, Discipline of Internal Medicine IV, "Victor Babeș" University of Medicine and Pharmacy, Timisoara, Romania
| | - Mihaela-Ioana Mariș
- Department of Functional Sciences, Pathophysiology, "Victor Babes" University of Medicine and Pharmacy, Timisoara, Romania
- Center for Translational Research and Systems Medicine, "Victor Babes" University of Medicine and Pharmacy, Timisoara, Romania
| | - Marius-Sorin Murariu
- Department of Surgery X, 1st Surgery Discipline, "Victor Babeș" University of Medicine and Pharmacy Timișoara, Timisoara, Romania
- Abdominal Surgery and Phlebology Research Center, "Victor Babes" University of Medicine and Pharmacy, Timisoara, Romania
| | - Sorin Olariu
- Department of Surgery X, 1st Surgery Discipline, "Victor Babeș" University of Medicine and Pharmacy Timișoara, Timisoara, Romania
- Abdominal Surgery and Phlebology Research Center, "Victor Babes" University of Medicine and Pharmacy, Timisoara, Romania
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Kumar A, Aravind N, Gillani T, Kumar D. Artificial intelligence breakthrough in diagnosis, treatment, and prevention of colorectal cancer – A comprehensive review. Biomed Signal Process Control 2025; 101:107205. [DOI: 10.1016/j.bspc.2024.107205] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/08/2024]
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Zhang C, Tao X, Pan J, Huang L, Dong Z, Lin J, Su H, Zhu Y, Du H, Xiao B, Chen M, Wu L, Yu H. The Effect of Computer-Aided Device on Adenoma Detection Rate in Different Implement Scenarios: A Real-World Study. J Gastroenterol Hepatol 2025; 40:692-705. [PMID: 39663912 DOI: 10.1111/jgh.16847] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/05/2024] [Revised: 11/11/2024] [Accepted: 11/24/2024] [Indexed: 12/13/2024]
Abstract
BACKGROUND Several recent studies have found that the efficacy of computer-aided polyp detection (CADe) on the adenoma detection rate (ADR) diminished in real-world settings. The role of unmeasured factors in AI-human interaction, such as monitor approaches, remains unknown. This study aimed to validate the effectiveness of CADe in the real world and assess the impact of monitor approaches. METHODS A retrospective propensity score-matched cohort study was conducted using routine data from a tertiary endoscopy center in China before and after the implementation of CADe. Four propensity score-matched cohorts were established: Cohort 1: pre-CADe matched with dual-monitor CADe-assisted group; Cohort 2: dual-monitor CADe-assisted with single-monitor CADe-assisted group; Cohort 3: pre-CADe with single-monitor CADe-assisted group; and Cohort 4: pre-CADe with CADe period. ADR was set as the primary outcome. RESULTS There were 5390, 6083, and 6131 eligible patients in the pre-CADe group, dual-monitor group, and single-monitor group, respectively. In the matched analysis, results indicated that regardless of the monitor setup, CADe-assisted groups showed a trend of increased ADR compared with the pre-CADe period (CADe period: OR 1.141, 95% CI 1.047-1.243; p = 0.003; dual-monitor: OR 1.178, 95% CI 1.069-1.299, p = 0.001; single-monitor: OR 1.094, 95% CI 0.998-1.200, p = 0.056). Moreover, no significant difference between different monitor approaches was observed, although dual-monitor setup showed an increasing tendency on ADR compared with single-monitor setup (OR 1.069, 95% CI 0.985-1.161, p = 0.109). CONCLUSION CADe shows great potential to improve ADR during colonoscopy in the real world. Meanwhile, changes in monitor setup do not significantly impact the assistance capability of CADe. Further research dedicated to evaluating the unmeasured elements in the AI-clinician hybrid for better implementation of CADe would be beneficial.
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Affiliation(s)
- Chenxia Zhang
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China
- Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China
- Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China
| | - Xiao Tao
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China
- Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China
- Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China
| | - Jie Pan
- Department of Gastroenterology, Wenzhou Central Hospital, Wenzhou, Zhejiang Province, China
- Department of Gastroenterology, The Dingli Clinical College of Wenzhou Medical University, Wenzhou, Zhejiang Province, China
- Department of Gastroenterology, The Second Affiliated Hospital of Shanghai University, Wenzhou, Zhejiang Province, China
| | - Li Huang
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China
- Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China
- Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China
| | - Zehua Dong
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China
- Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China
- Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China
| | - Jiejun Lin
- Department of Gastroenterology, Wenzhou Central Hospital, Wenzhou, Zhejiang Province, China
- Department of Gastroenterology, The Dingli Clinical College of Wenzhou Medical University, Wenzhou, Zhejiang Province, China
- Department of Gastroenterology, The Second Affiliated Hospital of Shanghai University, Wenzhou, Zhejiang Province, China
| | - Huang Su
- Department of Gastroenterology, Wenzhou Central Hospital, Wenzhou, Zhejiang Province, China
- Department of Gastroenterology, The Dingli Clinical College of Wenzhou Medical University, Wenzhou, Zhejiang Province, China
- Department of Gastroenterology, The Second Affiliated Hospital of Shanghai University, Wenzhou, Zhejiang Province, China
| | - Yijie Zhu
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China
- Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China
- Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China
| | - Hongliu Du
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China
- Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China
- Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China
| | - Bing Xiao
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China
- Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China
- Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China
| | - Mingkai Chen
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China
- Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China
- Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China
| | - Lianlian Wu
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China
- Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China
- Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China
| | - Honggang Yu
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China
- Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China
- Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China
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Zhong J, Zhu T, Huang Y. Reporting Quality of AI Intervention in Randomized Controlled Trials in Primary Care: Systematic Review and Meta-Epidemiological Study. J Med Internet Res 2025; 27:e56774. [PMID: 39998876 PMCID: PMC11897677 DOI: 10.2196/56774] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2024] [Revised: 12/21/2024] [Accepted: 01/22/2025] [Indexed: 02/27/2025] Open
Abstract
BACKGROUND The surge in artificial intelligence (AI) interventions in primary care trials lacks a study on reporting quality. OBJECTIVE This study aimed to systematically evaluate the reporting quality of both published randomized controlled trials (RCTs) and protocols for RCTs that investigated AI interventions in primary care. METHODS PubMed, Embase, Cochrane Library, MEDLINE, Web of Science, and CINAHL databases were searched for RCTs and protocols on AI interventions in primary care until November 2024. Eligible studies were published RCTs or full protocols for RCTs exploring AI interventions in primary care. The reporting quality was assessed using CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) and SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) checklists, focusing on AI intervention-related items. RESULTS A total of 11,711 records were identified. In total, 19 published RCTs and 21 RCT protocols for 35 trials were included. The overall proportion of adequately reported items was 65% (172/266; 95% CI 59%-70%) and 68% (214/315; 95% CI 62%-73%) for RCTs and protocols, respectively. The percentage of RCTs and protocols that reported a specific item ranged from 11% (2/19) to 100% (19/19) and from 10% (2/21) to 100% (21/21), respectively. The reporting of both RCTs and protocols exhibited similar characteristics and trends. They both lack transparency and completeness, which can be summarized in three aspects: without providing adequate information regarding the input data, without mentioning the methods for identifying and analyzing performance errors, and without stating whether and how the AI intervention and its code can be accessed. CONCLUSIONS The reporting quality could be improved in both RCTs and protocols. This study helps promote the transparent and complete reporting of trials with AI interventions in primary care.
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Affiliation(s)
- Jinjia Zhong
- School of General Practice and Continuing Education, Capital Medical University, Beijing, China
| | - Ting Zhu
- School of General Practice and Continuing Education, Capital Medical University, Beijing, China
| | - Yafang Huang
- School of General Practice and Continuing Education, Capital Medical University, Beijing, China
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Spadaccini M, Hassan C, Mori Y, Massimi D, Correale L, Facciorusso A, Patel HK, Rizkala T, Khalaf K, Ramai D, Rondonotti E, Maselli R, Rex DK, Bhandari P, Sharma P, Repici A. Variability in computer-aided detection effect on adenoma detection rate in randomized controlled trials: A meta-regression analysis. Dig Liver Dis 2025:S1590-8658(25)00205-1. [PMID: 39924430 DOI: 10.1016/j.dld.2025.01.192] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/25/2024] [Revised: 12/16/2024] [Accepted: 01/21/2025] [Indexed: 02/11/2025]
Abstract
BACKGROUND Computer-aided detection (CADe) systems may increase adenoma detection rate (ADR) during colonoscopy. However, the variable results of CADe effects in different RCTs warrant investigation into factors influencing these results. AIMS Investigate the different variables possibly affecting the impact of CADe-assisted colonoscopy and its effect on ADR. METHODS We searched MEDLINE, EMBASE, and Scopus databases until July 2023 for RCTs reporting performance of CADe systems in the detection of colorectal neoplasia. The main outcome was pooled ADR. A random-effects meta-analysis was performed to obtain the pooled risk ratios (RR) with 95 % confidence intervals (CI)). To explore sources of heterogeneity, we conducted a meta-regression analysis using both univariable and multivariable mixed-effects models. Potential explanatory variables included factors influencing adenoma prevalence, such as patient gender, age, and colonoscopy indication. We also included both key (ADR), and minor (Withdrawal time) performance measures considered as quality indicators for colonoscopy. RESULTS Twenty-three randomized controlled trials (RCTs) on 19,077 patients were include. ADR was higher in the CADe group (46 % [95 % CI 39-52]) than in the standard colonoscopy group (38 % [95 % CI 31-46]) with a risk ratio of 1.22 [95 % CI 1.14-1.29]); and a substantial level of heterogeneity (I2 = 67.69 %). In the univariable meta-regression analysis, patient age, ADR in control arms, and withdrawal time were the strongest predictors of CADe effect on ADR (P < .001). In multivariable meta-regression, ADR in control arms, and withdrawal time were simultaneous significant predictors of the proportion of the CADe effect on ADR. CONCLUSION The substantial level of heterogeneity found appeared to be associated with variability in colonoscopy quality performances across the studies, namely ADR in control arm, and withdrawal time.
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Affiliation(s)
- Marco Spadaccini
- Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Italy; Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy.
| | - Cesare Hassan
- Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Italy; Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy
| | - Yuichi Mori
- University of Oslo, Clinical Effectiveness Research Group, Oslo, Norway; Showa University Northern Yokohama Hospital, Digestive Disease Center, Yokohama, Japan
| | - Davide Massimi
- Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Italy; Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy
| | - Loredana Correale
- Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy
| | - Antonio Facciorusso
- University of Oslo, Clinical Effectiveness Research Group, Oslo, Norway; University of Salento, Gastroenterology Unit, Department of Experimental Medicine, Lecce, Italy
| | - Harsh K Patel
- Kansas City VA Medical Center, Gastroenterology and Hepatology, Kansas City, United States
| | - Tommy Rizkala
- Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Italy
| | - Kareem Khalaf
- St. Michael's Hospital, University of Toronto, Division of Gastroenterology, Toronto, Ontario, Canada
| | - Daryl Ramai
- University of Utah Health, Gastroenterology and Hepatology, Salt Lake City, UT, USA
| | | | - Roberta Maselli
- Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Italy; Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy
| | - Douglas K Rex
- Indiana University School of Medicine, Division of Gastroenterology, Indianapolis, Indiana, USA
| | - Pradeep Bhandari
- Queen Alexandra Hospital, Department of Gastroenterology, Portsmouth, UK
| | - Prateek Sharma
- Kansas City VA Medical Center, Gastroenterology and Hepatology, Kansas City, United States
| | - Alessandro Repici
- Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Italy; Humanitas Clinical and Research Center -IRCCS-, Endoscopy Unit, Rozzano, Italy
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Alali AA, Alhashmi A, Alotaibi N, Ali N, Alali M, Alfadhli A. Artificial Intelligence for Adenoma and Polyp Detection During Screening and Surveillance Colonoscopy: A Randomized-Controlled Trial. J Clin Med 2025; 14:581. [PMID: 39860586 PMCID: PMC11766411 DOI: 10.3390/jcm14020581] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/20/2024] [Revised: 12/31/2024] [Accepted: 01/15/2025] [Indexed: 01/27/2025] Open
Abstract
Background: Colorectal cancer (CRC) is the second leading cause of cancer death in Kuwait. The effectiveness of colonoscopy in preventing CRC is dependent on a high adenoma detection rate (ADR). Computer-aided detection can identify (CADe) and characterize polyps in real time and differentiate benign from neoplastic polyps, but its role remains unclear in screening colonoscopy. Methods: This was a randomized-controlled trial (RCT) enrolling patients 45 years of age or older presenting for outpatient screening or surveillance colonoscopy (Kuwait clinical trial registration number 2047/2022). Patients with a history of inflammatory bowel disease, alarm symptoms, familial polyposis syndrome, colon resection, or poor bowel preparation were excluded. Patients were randomly assigned to either high-definition white-light (HD-WL) colonoscopy (standard of care) or HD-WL colonoscopy with the CADe system. The primary outcome was ADR. The secondary outcomes included polyp detection rate (PDR), adenoma per colonoscopy (APC), polyp per colonoscopy (PPC), and accuracy of polyp characterization. Results: From 1 September 2022 to 1 March 2023, 102 patients were included and allocated to either the HD-WL colonoscopy group (n = 51) or CADe group (n = 51). The mean age was 52.8 years (SD 8.2), and males represented 50% of the cohort. Screening for CRC accounted for 94.1% of all examinations, while the remaining patients underwent surveillance colonoscopy. A total of 121 polyps were detected with an average size of 4.18 mm (SD 5.1), the majority being tubular adenomas with low-grade dysplasia (47.1%) and hyperplastic polyps (46.3%). There was no difference in the overall bowel preparation, insertion and withdrawal times, and adverse events between the two arms. ADR (primary outcome) was non-significantly higher in the CADe group compared to the HD colonoscopy group (47.1% vs. 37.3%, p = 0.3). Among the secondary outcomes, PDR (78.4% vs. 56.8%, p = 0.02) and PPC (1.35 vs. 0.96, p = 0.04) were significantly higher in the CADe group, but APC was not (0.75 vs. 0.51, p = 0.09). Accuracy in characterizing polyp histology was similar in both groups. Conclusions: In this RCT, the artificial intelligence system showed a non-significant trend towards improving ADR among Kuwaiti patients undergoing screening or surveillance colonoscopy compared to HD-WL colonoscopy alone, while it significantly improved the detection of diminutive polyps. A larger multicenter study is required to detect the true effect of CADe on the detection of adenomas.
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Affiliation(s)
- Ali A. Alali
- Department of Medicine, Faculty of Medicine, Kuwait University, Jabriyah 13110, Kuwait
- Thunayan Alghanim Gastroenterology Center, Amiri Hospital, Sharq 15300, Kuwait
| | - Ahmad Alhashmi
- Department of Medicine, Faculty of Medicine, Kuwait University, Jabriyah 13110, Kuwait
| | - Nawal Alotaibi
- Department of Medicine, Jaber Alahmad Hospital, Zahra 47761, Kuwait
| | - Nargess Ali
- Department of Medicine, Faculty of Medicine, Kuwait University, Jabriyah 13110, Kuwait
| | - Maryam Alali
- Haya Al-Habeeb Gastroenterology Center, Mubarak Alkabeer Hospital, Jabriyah 13110, Kuwait
| | - Ahmad Alfadhli
- Haya Al-Habeeb Gastroenterology Center, Mubarak Alkabeer Hospital, Jabriyah 13110, Kuwait
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Liu J, Zhou R, Liu C, Liu H, Cui Z, Guo Z, Zhao W, Zhong X, Zhang X, Li J, Wang S, Xing L, Zhao Y, Ma R, Ni J, Li Z, Li Y, Zuo X. Automatic Quality Control System and Adenoma Detection Rates During Routine Colonoscopy: A Randomized Clinical Trial. JAMA Netw Open 2025; 8:e2457241. [PMID: 39883463 PMCID: PMC11783196 DOI: 10.1001/jamanetworkopen.2024.57241] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2024] [Accepted: 11/25/2024] [Indexed: 01/31/2025] Open
Abstract
Importance High-quality colonoscopy reduces the risks of colorectal cancer by increasing the adenoma detection rate. Routine use of an automatic quality control system (AQCS) to assist in colorectal adenoma detection should be considered. Objective To evaluate the effect of an AQCS on the adenoma detection rate among colonoscopists who were moderate- and low-level detectors during routine colonoscopy. Design, Setting, and Participants This multicenter, single-blind, randomized clinical trial was conducted at 6 centers in China from August 1, 2021, to September 30, 2022. Data were analyzed from March 1 to June 30, 2023. Individuals aged 18 to 80 years were enrolled. Exclusion criteria were a history of inflammatory bowel disease, advanced colorectal cancer, and polyposis syndromes; known colorectal polyps without complete removal previously; a history of colorectal surgery; known stenosis or obstruction with contraindication for biopsy or prior failed colonoscopy; pregnancy or lactation; and refusal to participate. Intention-to-treat and per-protocol analysis was used. Interventions Standard colonoscopy or AQCS-assisted colonoscopy. Main Outcomes and Measures Adenoma detection rate. Results A total of 1254 participants (mean [SD] age, 51.21 [12.10] years; 674 [53.7%] male) were randomized (627 standard colonoscopy, 627 AQCS-assisted colonoscopy). Intention-to-treat analysis showed a significantly higher adenoma detection rate in the AQCS-assisted group vs standard colonoscopy group (32.7% vs 22.6%; relative risk [RR], 1.60; 95% CI, 1.23-2.09; P < .001). The adenoma detection rates were significantly higher in the AQCS group when considering pathology (nonadvanced adenomas, 30.1% vs 21.2%; RR, 1.52; 95% CI, 1.16-1.99; P = .002), and morphology (flat or sessile, 29.3% vs 20.4%, RR, 1.52; 95% CI, 1.16-2.00; P = .003). Use of AQCS significantly increased the adenoma detection rate of both the lower-level detectors (30.0% vs 20.0%; RR, 1.71; 95% CI, 1.24-2.35; P = .001) and the medium-level detectors (38.1% vs 27.7%; RR, 1.61; 95% CI, 1.07-2.43; P = .02). Similar increases were found for adenoma detection rates in the academic and nonacademic centers (academic: 29.3% vs 20.8%; RR, 1.58; 95% CI, 1.10-2.29; P = .01; nonacademic: 36.1% vs 24.5%; RR, 1.74; 95% CI, 1.23-2.46; P = .002). The number of adenomas per colonoscopy was significantly higher in the AQCS-assisted group (0.86 vs 0.48; RR, 1.50; 95% CI, 1.17-1.91; P = .001). The mean withdrawal time without intervention was slightly increased with AQCS assistance (6.78 vs 6.46 minutes; RR, 1.38; 95% CI, 1.26-1.52; P < .001). No serious adverse events were reported. Conclusions and Relevance In this randomized clinical trial, AQCS assistance during routine colonoscopy increased adenoma detection rates and several related polyp parameters compared with standard colonoscopy in the lower- and medium-level detectors in academic and nonacademic settings. Routine use of AQCS to assist in colorectal adenoma detection and quality improvement should be considered. Trial Registration ClinicalTrials.gov Identifier: NCT04901130.
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Affiliation(s)
- Jing Liu
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Department of Gastroenterology, Qilu Hospital of Shandong University, Qingdao, Shandong, China
| | - Ruchen Zhou
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Chengxia Liu
- Department of Gastroenterology, Binzhou Medical University Hospital, Binzhou, Shandong, China
| | - Haiyan Liu
- Department of Gastroenterology, Binzhou Medical University Hospital, Binzhou, Shandong, China
- Department of Gastroenterology, The First School of Clinical Medicine of Binzhou Medical University, Binzhou, Shandong, China
| | - Zhenqin Cui
- Department of Gastroenterology, Central Hospital of Shengli Oilfield, Dongying, Shandong, China
| | - Zhuang Guo
- Department of Gastroenterology, Central Hospital of Shengli Oilfield, Dongying, Shandong, China
| | - Weidong Zhao
- Department of Gastroenterology, Zibo Municipal Hospital, Zibo, Shandong, China
| | - Xiaoqin Zhong
- Department of Gastroenterology, Zibo Municipal Hospital, Zibo, Shandong, China
| | - Xiaodong Zhang
- Department of Gastroenterology, Linyi People’s Hospital, Dezhou, Shandong, China
| | - Jing Li
- Department of Gastroenterology, Linyi People’s Hospital, Dezhou, Shandong, China
| | - Shihuan Wang
- Department of Gastroenterology, The People’s Hospital of Zhaoyuan City, Yantai, Shandong, China
| | - Li Xing
- Department of Gastroenterology, The People’s Hospital of Zhaoyuan City, Yantai, Shandong, China
| | - Yusha Zhao
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Ruiguang Ma
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Jiekun Ni
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Zhen Li
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Yanqing Li
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Xiuli Zuo
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Department of Gastroenterology, Qilu Hospital of Shandong University, Qingdao, Shandong, China
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Makar J, Abdelmalak J, Con D, Hafeez B, Garg M. Use of artificial intelligence improves colonoscopy performance in adenoma detection: a systematic review and meta-analysis. Gastrointest Endosc 2025; 101:68-81.e8. [PMID: 39216648 DOI: 10.1016/j.gie.2024.08.033] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/08/2024] [Revised: 08/17/2024] [Accepted: 08/27/2024] [Indexed: 09/04/2024]
Abstract
BACKGROUND AND AIMS Artificial intelligence (AI) is increasingly used to improve adenoma detection during colonoscopy. This meta-analysis aimed to provide an updated evaluation of computer-aided detection (CADe) systems and their impact on key colonoscopy quality indicators. METHODS We searched the EMBASE, PubMed, and MEDLINE databases from inception until February 15, 2024, for randomized control trials (RCTs) comparing the performance of CADe systems with routine unassisted colonoscopy in the detection of colorectal adenomas. RESULTS Twenty-eight RCTs were selected for inclusion involving 23,861 participants. Random-effects meta-analysis demonstrated a 20% increase in adenoma detection rate (risk ratio [RR], 1.20; 95% confidence interval [CI], 1.14-1.27; P < .01) and 55% decrease in adenoma miss rate (RR, 0.45; 95% CI, 0.37-0.54; P < .01) with AI-assisted colonoscopy. Subgroup analyses involving only expert endoscopists demonstrated a similar effect size (RR, 1.19; 95% CI, 1.11-1.27; P < .001), with similar findings seen in analysis of differing CADe systems and healthcare settings. CADe use also significantly increased adenomas per colonoscopy (weighted mean difference, 0.21; 95% CI, 0.14-0.29; P < .01), primarily because of increased diminutive lesion detection, with no significant difference seen in detection of advanced adenomas. Sessile serrated lesion detection (RR, 1.10; 95% CI, 0.93-1.30; P = .27) and miss rates (RR, 0.44; 95% CI, 0.16-1.19; P = .11) were similar. There was an average 0.15-minute prolongation of withdrawal time with AI-assisted colonoscopy (weighted mean difference, 0.15; 95% CI, 0.04-0.25; P = .01) and a 39% increase in the rate of non-neoplastic resection (RR, 1.39; 95% CI, 1.23-1.57; P < .001). CONCLUSIONS AI-assisted colonoscopy significantly improved adenoma detection but not sessile serrated lesion detection irrespective of endoscopist experience, system type, or healthcare setting.
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Affiliation(s)
- Jonathan Makar
- Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia
| | - Jonathan Abdelmalak
- Department of Gastroenterology, Austin Hospital, Heidelberg, Victoria, Australia; Department of Gastroenterology, Alfred Hospital, Melbourne, Victoria, Australia; Central Clinical School, Monash University, Melbourne, Victoria, Australia
| | - Danny Con
- Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia; Department of Gastroenterology, Austin Hospital, Heidelberg, Victoria, Australia
| | - Bilal Hafeez
- Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia
| | - Mayur Garg
- Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia; Department of Gastroenterology, Northern Health, Epping, Victoria, Australia
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Li S, Xu M, Meng Y, Sun H, Zhang T, Yang H, Li Y, Ma X. The application of the combination between artificial intelligence and endoscopy in gastrointestinal tumors. MEDCOMM – ONCOLOGY 2024; 3. [DOI: 10.1002/mog2.91] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/29/2023] [Accepted: 09/03/2024] [Indexed: 01/04/2025]
Abstract
AbstractGastrointestinal (GI) tumors have always been a major type of malignant tumor and a leading cause of tumor‐related deaths worldwide. The main principles of modern medicine for GI tumors are early prevention, early diagnosis, and early treatment, with early diagnosis being the most effective measure. Endoscopy, due to its ability to visualize lesions, has been one of the primary modalities for screening, diagnosing, and treating GI tumors. However, a qualified endoscopist often requires long training and extensive experience, which to some extent limits the wider use of endoscopy. With advances in data science, artificial intelligence (AI) has brought a new development direction for the endoscopy of GI tumors. AI can quickly process large quantities of data and images and improve diagnostic accuracy with some training, greatly reducing the workload of endoscopists and assisting them in early diagnosis. Therefore, this review focuses on the combined application of endoscopy and AI in GI tumors in recent years, describing the latest research progress on the main types of tumors and their performance in clinical trials, the application of multimodal AI in endoscopy, the development of endoscopy, and the potential applications of AI within it, with the aim of providing a reference for subsequent research.
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Affiliation(s)
- Shen Li
- Department of Biotherapy Cancer Center, West China Hospital, West China Medical School Sichuan University Chengdu China
| | - Maosen Xu
- Laboratory of Aging Research and Cancer Drug Target, State Key Laboratory of Biotherapy, West China Hospital, National Clinical Research, Sichuan University Chengdu Sichuan China
| | - Yuanling Meng
- West China School of Stomatology Sichuan University Chengdu Sichuan China
| | - Haozhen Sun
- College of Life Sciences Sichuan University Chengdu Sichuan China
| | - Tao Zhang
- Department of Biotherapy Cancer Center, West China Hospital, West China Medical School Sichuan University Chengdu China
| | - Hanle Yang
- Department of Biotherapy Cancer Center, West China Hospital, West China Medical School Sichuan University Chengdu China
| | - Yueyi Li
- Department of Biotherapy Cancer Center, West China Hospital, West China Medical School Sichuan University Chengdu China
| | - Xuelei Ma
- Department of Biotherapy Cancer Center, West China Hospital, West China Medical School Sichuan University Chengdu China
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11
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Soleymanjahi S, Huebner J, Elmansy L, Rajashekar N, Lüdtke N, Paracha R, Thompson R, Grimshaw AA, Foroutan F, Sultan S, Shung DL. Artificial Intelligence-Assisted Colonoscopy for Polyp Detection : A Systematic Review and Meta-analysis. Ann Intern Med 2024; 177:1652-1663. [PMID: 39531400 DOI: 10.7326/annals-24-00981] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2024] Open
Abstract
BACKGROUND Randomized clinical trials (RCTs) of computer-aided detection (CADe) system-enhanced colonoscopy compared with conventional colonoscopy suggest increased adenoma detection rate (ADR) and decreased adenoma miss rate (AMR), but the effect on detection of advanced colorectal neoplasia (ACN) is unclear. PURPOSE To conduct a systematic review to compare performance of CADe-enhanced and conventional colonoscopy. DATA SOURCES Cochrane Library, Google Scholar, Ovid EMBASE, Ovid MEDLINE, PubMed, Scopus, and Web of Science Core Collection databases were searched through February 2024. STUDY SELECTION Published RCTs comparing CADe-enhanced and conventional colonoscopy. DATA EXTRACTION Average adenoma per colonoscopy (APC) and ACN per colonoscopy were primary outcomes. Adenoma detection rate, AMR, and ACN detection rate (ACN DR) were secondary outcomes. Balancing outcomes included withdrawal time and resection of nonneoplastic polyps (NNPs). Subgroup analyses were done by neural network architecture. DATA SYNTHESIS Forty-four RCTs with 36 201 cases were included. Computer-aided detection-enhanced colonoscopies have higher average APC (12 090 of 12 279 [0.98] vs. 9690 of 12 292 [0.78], incidence rate difference [IRD] = 0.22 [95% CI, 0.16 to 0.28]) and higher ADR (7098 of 16 253 [44.7%] vs. 5825 of 15 855 [36.7%], rate ratio [RR] = 1.21 [CI, 1.15 to 1.28]). Average ACN per colonoscopy was similar (1512 of 9296 [0.16] vs. 1392 of 9121 [0.15], IRD = 0.01 [CI, -0.01 to 0.02]), but ACN DR was higher with CADe system use (1260 of 9899 [12.7%] vs. 1119 of 9746 [11.5%], RR = 1.16 [CI, 1.02 to 1.32]). Using CADe systems resulted in resection of almost 2 extra NNPs per 10 colonoscopies and longer total withdrawal time (0.53 minutes [CI, 0.30 to 0.77]). LIMITATION Statistically significant heterogeneity in quality and sample size and inability to blind endoscopists to the intervention in included studies may affect the performance estimates. CONCLUSION Computer-aided detection-enhanced colonoscopies have increased APC and detection rate but no difference in ACN per colonoscopy and a small increase in ACN DR. There is minimal increase in procedure time and no difference in performance across neural network architectures. PRIMARY FUNDING SOURCE None. (PROSPERO: CRD42023422835).
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Affiliation(s)
- Saeed Soleymanjahi
- Division of Gastroenterology, Mass General Brigham, Harvard School of Medicine, Boston, Massachusetts (S.Soleymanjahi)
| | - Jack Huebner
- Department of Medicine, Yale School of Medicine, New Haven, Connecticut (J.H., L.E., N.R., R.P., R.T.)
| | - Lina Elmansy
- Department of Medicine, Yale School of Medicine, New Haven, Connecticut (J.H., L.E., N.R., R.P., R.T.)
| | - Niroop Rajashekar
- Department of Medicine, Yale School of Medicine, New Haven, Connecticut (J.H., L.E., N.R., R.P., R.T.)
| | - Nando Lüdtke
- Section of Digestive Diseases, Department of Medicine, Yale School of Medicine, New Haven, Connecticut (N.L.)
| | - Rumzah Paracha
- Department of Medicine, Yale School of Medicine, New Haven, Connecticut (J.H., L.E., N.R., R.P., R.T.)
| | - Rachel Thompson
- Department of Medicine, Yale School of Medicine, New Haven, Connecticut (J.H., L.E., N.R., R.P., R.T.)
| | - Alyssa A Grimshaw
- Cushing/Whitney Medical Library, Yale University, New Haven, Connecticut (A.A.G.)
| | | | - Shahnaz Sultan
- Division of Gastroenterology, Hepatology and Nutrition, University of Minnesota, Minneapolis, Minnesota (S.Sultan)
| | - Dennis L Shung
- Section of Digestive Diseases, Clinical and Translational Research Accelerator, and Department of Biomedical Informatics and Data Science, Department of Medicine, Yale School of Medicine, New Haven, Connecticut (D.L.S.)
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12
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Sinonquel P, Eelbode T, Pech O, De Wulf D, Dewint P, Neumann H, Antonelli G, Iacopini F, Tate D, Lemmers A, Pilonis ND, Kaminski MF, Roelandt P, Hassan C, Ingrid D, Maes F, Bisschops R. Clinical consequences of computer-aided colorectal polyp detection. Gut 2024; 73:1974-1983. [PMID: 38876773 DOI: 10.1136/gutjnl-2024-331943] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/12/2024] [Accepted: 06/02/2024] [Indexed: 06/16/2024]
Abstract
BACKGROUND AND AIM Randomised trials show improved polyp detection with computer-aided detection (CADe), mostly of small lesions. However, operator and selection bias may affect CADe's true benefit. Clinical outcomes of increased detection have not yet been fully elucidated. METHODS In this multicentre trial, CADe combining convolutional and recurrent neural networks was used for polyp detection. Blinded endoscopists were monitored in real time by a second observer with CADe access. CADe detections prompted reinspection. Adenoma detection rates (ADR) and polyp detection rates were measured prestudy and poststudy. Histological assessments were done by independent histopathologists. The primary outcome compared polyp detection between endoscopists and CADe. RESULTS In 946 patients (51.9% male, mean age 64), a total of 2141 polyps were identified, including 989 adenomas. CADe was not superior to human polyp detection (sensitivity 94.6% vs 96.0%) but outperformed them when restricted to adenomas. Unblinding led to an additional yield of 86 true positive polyp detections (1.1% ADR increase per patient; 73.8% were <5 mm). CADe also increased non-neoplastic polyp detection by an absolute value of 4.9% of the cases (1.8% increase of entire polyp load). Procedure time increased with 6.6±6.5 min (+42.6%). In 22/946 patients, the additional detection of adenomas changed surveillance intervals (2.3%), mostly by increasing the number of small adenomas beyond the cut-off. CONCLUSION Even if CADe appears to be slightly more sensitive than human endoscopists, the additional gain in ADR was minimal and follow-up intervals rarely changed. Additional inspection of non-neoplastic lesions was increased, adding to the inspection and/or polypectomy workload.
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Affiliation(s)
- Pieter Sinonquel
- Gastroenterology and Hepatology, UZ Leuven, Leuven, Belgium
- Translational Research in Gastrointestinal Diseases (TARGID), KU Leuven Biomedical Sciences Group, Leuven, Belgium
| | - Tom Eelbode
- Electrical Engineering (ESAT/PSI), KU Leuven, Leuven, Belgium
| | - Oliver Pech
- Gastroenterology and Hepatology, Krankenhaus Barmherzige Bruder Regensburg, Regensburg, Germany
| | - Dominiek De Wulf
- Gastroenterology and Hepatology, AZ Delta vzw, Roeselare, Belgium
| | - Pieter Dewint
- Gastroenterology and Hepatology, AZ Maria Middelares vzw, Gent, Belgium
| | - Helmut Neumann
- Gastroenterology and Hepatology, Gastrozentrum Lippe, Bad Salzuflen, Germany
| | - Giulio Antonelli
- Gastroenterology and Digestive Endoscopy Unit, Ospedale Nuovo Regina Margherita, Roma, Italy
| | - Federico Iacopini
- Gastroenterology and Digestive endoscopy, Ospedale dei Castelli, Ariccia, Italy
| | - David Tate
- Gastroenterology and Hepatology, UZ Gent, Gent, Belgium
| | - Arnaud Lemmers
- Gastroenterology and Hepatology, ULB Erasme, Bruxelles, Belgium
| | | | - Michal Filip Kaminski
- Department of Gastroenterology, Hepatology and Oncology, Medical Centre fo Postgraduate Education, Warsaw, Poland
- Department of Gastroenterological Oncology, The Maria Sklodowska-Curie Memorial Cancer Centre, Instytute of Oncology, Warsaw, Poland
| | - Philip Roelandt
- Gastroenterology and Hepatology, UZ Leuven, Leuven, Belgium
- Translational Research in Gastrointestinal Diseases (TARGID), KU Leuven Biomedical Sciences Group, Leuven, Belgium
| | - Cesare Hassan
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- IRCCS Humanitas Research Hospital, Milan, Italy
| | - Demedts Ingrid
- Gastroenterology and Hepatology, UZ Leuven, Leuven, Belgium
- Translational Research in Gastrointestinal Diseases (TARGID), KU Leuven Biomedical Sciences Group, Leuven, Belgium
| | - Frederik Maes
- Electrical Engineering (ESAT/PSI), KU Leuven, Leuven, Belgium
| | - Raf Bisschops
- Gastroenterology and Hepatology, UZ Leuven, Leuven, Belgium
- Translational Research in Gastrointestinal Diseases (TARGID), KU Leuven Biomedical Sciences Group, Leuven, Belgium
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13
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Maas MHJ, Rath T, Spada C, Soons E, Forbes N, Kashin S, Cesaro P, Eickhoff A, Vanbiervliet G, Salvi D, Belletrutti PJ, Siersema PD, for the Discovery study team . A computer-aided detection system in the everyday setting of diagnostic, screening, and surveillance colonoscopy: an international, randomized trial. Endoscopy 2024; 56:843-850. [PMID: 38749482 PMCID: PMC11524745 DOI: 10.1055/a-2328-2844] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/10/2024] [Accepted: 05/15/2024] [Indexed: 06/29/2024]
Abstract
BACKGROUND Computer-aided detection (CADe) has been developed to improve detection during colonoscopy. After initial reports of high efficacy, there has been an increasing recognition of variability in the effectiveness of CADe systems. The aim of this study was to evaluate a CADe system in a varied colonoscopy population. METHODS A multicenter, randomized trial was conducted at seven hospitals (both university and non-university) in Europe and Canada. Participants referred for diagnostic, non-immunochemical fecal occult blood test (iFOBT) screening, or surveillance colonoscopy were randomized (1:1) to undergo CADe-assisted or conventional colonoscopy by experienced endoscopists. Participants with insufficient bowel preparation were excluded from the analysis. The primary outcome was adenoma detection rate (ADR). Secondary outcomes included adenomas per colonoscopy (APC) and sessile serrated lesions (SSLs) per colonoscopy. RESULTS 581 participants were enrolled, of whom 497 were included in the final analysis: 250 in the CADe arm and 247 in the conventional colonoscopy arm. The indication was surveillance in 202/497 colonoscopies (40.6 %), diagnostic in 199/497 (40.0 %), and non-iFOBT screening in 96/497 (19.3 %). Overall, ADR (38.4 % vs. 37.7 %; P = 0.43) and APC (0.66 vs. 0.66; P = 0.97) were similar between CADe and conventional colonoscopy. SSLs per colonoscopy was increased (0.30 vs. 0.19; P = 0.049) in the CADe arm vs. the conventional colonoscopy arm. CONCLUSIONS In this study conducted by experienced endoscopists, CADe did not result in a statistically significant increase in ADR. However, the ADR of our control group substantially surpassed our sample size assumptions, increasing the risk of an underpowered trial.
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Affiliation(s)
- Michiel H. J. Maas
- Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands
| | - Timo Rath
- Department of Medicine I, Division of Gastroenterology, Universitätsklinikum Erlangen, Erlangen, Germany
| | - Cristiano Spada
- Department of Gastroenterology and Endoscopy, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
- Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
| | - Elsa Soons
- Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands
| | - Nauzer Forbes
- Department of Medicine, University of Calgary, Calgary, Canada
| | - Sergey Kashin
- Department of Endoscopy, Yaroslavl Regional Cancer Hospital, Yaroslavl, Russia
| | - Paola Cesaro
- Department of Gastroenterology and Endoscopy, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
| | - Axel Eickhoff
- Gastroenterology, Diabetology, Infectiology, Klinikum Hanau, Hanau, Germany
| | | | - Daniele Salvi
- Department of Gastroenterology and Endoscopy, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
- Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
| | | | - Peter D. Siersema
- Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands
- ErasmusMC – University Medical Center, Rotterdam, the Netherlands
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14
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Martinez M, Bartel MJ, Chua T, Dakhoul L, Fatima H, Jensen D, Lara LF, Tadros M, Villa E, Yang D, Saltzman JR. The 2023 top 10 list of endoscopy topics in medical publishing: an annual review by the American Society for Gastrointestinal Endoscopy Editorial Board. Gastrointest Endosc 2024; 100:537-548. [PMID: 38729314 DOI: 10.1016/j.gie.2024.05.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/21/2024] [Accepted: 05/01/2024] [Indexed: 05/12/2024]
Abstract
Using a systematic literature search of original articles published during 2023 in Gastrointestinal Endoscopy (GIE) and other high-impact medical and gastroenterology journals, the GIE Editorial Board of the American Society for Gastrointestinal Endoscopy compiled a list of the top 10 most significant topic areas in general and advanced GI endoscopy during the year. Each GIE Editorial Board member was directed to consider 3 criteria in generating candidate topics-significance, novelty, and impact on global clinical practice-and subject matter consensus was facilitated by the Chair through electronic voting and a meeting of the entire GIE Editorial Board. The 10 identified areas collectively represent advances in the following endoscopic spheres: GI bleeding, endohepatology, endoscopic palliation, artificial intelligence and polyp detection, artificial intelligence beyond the colon, better polypectomy and EMR, how to make endoscopy units greener, high-quality upper endoscopy, endoscopic tissue apposition and closure devices, and endoscopic submucosal dissection. Each board member was assigned a topic area around which to summarize relevant important articles, thereby generating this overview of the "top 10" endoscopic advances of 2023.
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Affiliation(s)
- Melissa Martinez
- Digestive Health Institute, Carle Foundation Hospital, Urbana, Illinois, USA
| | | | - Tiffany Chua
- Department of Gastroenterology, Hepatology and Nutrition, University of Florida, Gainesville, Florida, USA
| | - Lara Dakhoul
- Department of Gastroenterology, Hepatology and Nutrition, University of Florida, Gainesville, Florida, USA
| | - Hala Fatima
- Department of Internal Medicine, Division of Gastroenterology, Indiana University School of Medicine, Indianapolis, Indiana, USA
| | - Dennis Jensen
- Ronald Reagan UCLA Medical Center and The VA Greater Los Angeles Healthcare System, David Geffen School of Medicine at UCLA, Los Angeles, California, USA
| | - Luis F Lara
- Division of Digestive Diseases, University of Cincinnati, Cincinnati, Ohio, USA
| | - Michael Tadros
- Division of Gastroenterology, Albany Medical Center, Albany, New York, USA
| | | | - Dennis Yang
- Center of Interventional Endoscopy, Advent Health, Orlando, Florida, USA
| | - John R Saltzman
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA
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15
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Khouri A, Dickson C, Green A, Hanjar A, Sonnier W. Effect of computer aided detection device on the adenoma detection rate and serrated detection rate among trainee fellows. JGH Open 2024; 8:e70018. [PMID: 39253018 PMCID: PMC11382257 DOI: 10.1002/jgh3.70018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2024] [Revised: 07/13/2024] [Accepted: 08/07/2024] [Indexed: 09/11/2024]
Abstract
Background and Aims The utilization of artificial intelligence (AI) with computer-aided detection (CADe) has the potential to increase the adenoma detection rate (ADR) by up to 30% in expert settings and specialized centers. The impact of CADe on serrated polyp detection rates (SDR) and academic trainees ADR & SDR remains underexplored. We aim to investigate the effect of CADe on ADR and SDR at an academic center with various levels of providers' experience. Methods A single-center retrospective analysis was conducted on asymptomatic patients between the ages of 45 and 75 who underwent screening colonoscopy. Colonoscopy reports were reviewed for 3 months prior to the introduction of GI Genius™ (Medtronic, USA) and 3 months after its implementation. The primary outcome was ADR and SDR with and without CADe. Results Totally 658 colonoscopies were eligible for analysis. CADe resulted in statistically significant improvement in SDR from 8.92% to 14.1% (P = 0.037). The (ADR + SDR) with CADe and without CADe was 58% and 55.1%, respectively (P = 0.46). Average colonoscopy (CSC) withdrawal time was 17.33 min (SD 10) with the device compared with 17.35 min (SD 9) without the device (P = 0.98). Conclusion In this study, GI Genius™ was associated with a statistically significant increase in SDR alone, but not in ADR or (ADR + SDR), likely secondary to the more elusive nature of serrated polyps compared to adenomatous polyps. The use of CADe did not affect withdrawal time.
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Affiliation(s)
- Anas Khouri
- Department of Internal Medicine and Division of Gastroenterology University of South Alabama Frederick P. Whiddon College of Medicine Mobile Alabama USA
| | - Chance Dickson
- Department of Internal Medicine and Division of Gastroenterology University of South Alabama Frederick P. Whiddon College of Medicine Mobile Alabama USA
| | - Alvin Green
- Department of Internal Medicine and Division of Gastroenterology University of South Alabama Frederick P. Whiddon College of Medicine Mobile Alabama USA
| | - Abrahim Hanjar
- Department of Internal Medicine and Division of Gastroenterology University of South Alabama Frederick P. Whiddon College of Medicine Mobile Alabama USA
| | - William Sonnier
- Department of Internal Medicine and Division of Gastroenterology University of South Alabama Frederick P. Whiddon College of Medicine Mobile Alabama USA
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Kikuchi R, Okamoto K, Ozawa T, Shibata J, Ishihara S, Tada T. Endoscopic Artificial Intelligence for Image Analysis in Gastrointestinal Neoplasms. Digestion 2024; 105:419-435. [PMID: 39068926 DOI: 10.1159/000540251] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/15/2024] [Accepted: 07/02/2024] [Indexed: 07/30/2024]
Abstract
BACKGROUND Artificial intelligence (AI) using deep learning systems has recently been utilized in various medical fields. In the field of gastroenterology, AI is primarily implemented in image recognition and utilized in the realm of gastrointestinal (GI) endoscopy. In GI endoscopy, computer-aided detection/diagnosis (CAD) systems assist endoscopists in GI neoplasm detection or differentiation of cancerous or noncancerous lesions. Several AI systems for colorectal polyps have already been applied in colonoscopy clinical practices. In esophagogastroduodenoscopy, a few CAD systems for upper GI neoplasms have been launched in Asian countries. The usefulness of these CAD systems in GI endoscopy has been gradually elucidated. SUMMARY In this review, we outline recent articles on several studies of endoscopic AI systems for GI neoplasms, focusing on esophageal squamous cell carcinoma (ESCC), esophageal adenocarcinoma (EAC), gastric cancer (GC), and colorectal polyps. In ESCC and EAC, computer-aided detection (CADe) systems were mainly developed, and a recent meta-analysis study showed sensitivities of 91.2% and 93.1% and specificities of 80% and 86.9%, respectively. In GC, a recent meta-analysis study on CADe systems demonstrated that their sensitivity and specificity were as high as 90%. A randomized controlled trial (RCT) also showed that the use of the CADe system reduced the miss rate. Regarding computer-aided diagnosis (CADx) systems for GC, although RCTs have not yet been conducted, most studies have demonstrated expert-level performance. In colorectal polyps, multiple RCTs have shown the usefulness of the CADe system for improving the polyp detection rate, and several CADx systems have been shown to have high accuracy in colorectal polyp differentiation. KEY MESSAGES Most analyses of endoscopic AI systems suggested that their performance was better than that of nonexpert endoscopists and equivalent to that of expert endoscopists. Thus, endoscopic AI systems may be useful for reducing the risk of overlooking lesions and improving the diagnostic ability of endoscopists.
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Affiliation(s)
- Ryosuke Kikuchi
- Department of Surgical Oncology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan
| | - Kazuaki Okamoto
- Department of Surgical Oncology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan
| | - Tsuyoshi Ozawa
- Tomohiro Tada the Institute of Gastroenterology and Proctology, Saitama, Japan
- AI Medical Service Inc., Tokyo, Japan
| | - Junichi Shibata
- Tomohiro Tada the Institute of Gastroenterology and Proctology, Saitama, Japan
- AI Medical Service Inc., Tokyo, Japan
| | - Soichiro Ishihara
- Department of Surgical Oncology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan
| | - Tomohiro Tada
- Department of Surgical Oncology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan
- Tomohiro Tada the Institute of Gastroenterology and Proctology, Saitama, Japan
- AI Medical Service Inc., Tokyo, Japan
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17
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Introzzi L, Zonca J, Cabitza F, Cherubini P, Reverberi C. Enhancing human-AI collaboration: The case of colonoscopy. Dig Liver Dis 2024; 56:1131-1139. [PMID: 37940501 DOI: 10.1016/j.dld.2023.10.018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/03/2023] [Revised: 10/19/2023] [Accepted: 10/23/2023] [Indexed: 11/10/2023]
Abstract
Diagnostic errors impact patient health and healthcare costs. Artificial Intelligence (AI) shows promise in mitigating this burden by supporting Medical Doctors in decision-making. However, the mere display of excellent or even superhuman performance by AI in specific tasks does not guarantee a positive impact on medical practice. Effective AI assistance should target the primary causes of human errors and foster effective collaborative decision-making with human experts who remain the ultimate decision-makers. In this narrative review, we apply these principles to the specific scenario of AI assistance during colonoscopy. By unraveling the neurocognitive foundations of the colonoscopy procedure, we identify multiple bottlenecks in perception, attention, and decision-making that contribute to diagnostic errors, shedding light on potential interventions to mitigate them. Furthermore, we explored how existing AI devices fare in clinical practice and whether they achieved an optimal integration with the human decision-maker. We argue that to foster optimal Human-AI collaboration, future research should expand our knowledge of factors influencing AI's impact, establish evidence-based cognitive models, and develop training programs based on them. These efforts will enhance human-AI collaboration, ultimately improving diagnostic accuracy and patient outcomes. The principles illuminated in this review hold more general value, extending their relevance to a wide array of medical procedures and beyond.
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Affiliation(s)
- Luca Introzzi
- Department of Psychology, Università Milano - Bicocca, Milano, Italy
| | - Joshua Zonca
- Department of Psychology, Università Milano - Bicocca, Milano, Italy; Milan Center for Neuroscience, Università Milano - Bicocca, Milano, Italy
| | - Federico Cabitza
- Department of Informatics, Systems and Communication, Università Milano - Bicocca, Milano, Italy; IRCCS Istituto Ortopedico Galeazzi, Milano, Italy
| | - Paolo Cherubini
- Department of Brain and Behavioral Sciences, Università Statale di Pavia, Pavia, Italy
| | - Carlo Reverberi
- Department of Psychology, Università Milano - Bicocca, Milano, Italy; Milan Center for Neuroscience, Università Milano - Bicocca, Milano, Italy.
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18
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Spadaccini M, Troya J, Khalaf K, Facciorusso A, Maselli R, Hann A, Repici A. Artificial Intelligence-assisted colonoscopy and colorectal cancer screening: Where are we going? Dig Liver Dis 2024; 56:1148-1155. [PMID: 38458884 DOI: 10.1016/j.dld.2024.01.203] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/12/2023] [Revised: 01/22/2024] [Accepted: 01/23/2024] [Indexed: 03/10/2024]
Abstract
Colorectal cancer is a significant global health concern, necessitating effective screening strategies to reduce its incidence and mortality rates. Colonoscopy plays a crucial role in the detection and removal of colorectal neoplastic precursors. However, there are limitations and variations in the performance of endoscopists, leading to missed lesions and suboptimal outcomes. The emergence of artificial intelligence (AI) in endoscopy offers promising opportunities to improve the quality and efficacy of screening colonoscopies. In particular, AI applications, including computer-aided detection (CADe) and computer-aided characterization (CADx), have demonstrated the potential to enhance adenoma detection and optical diagnosis accuracy. Additionally, AI-assisted quality control systems aim to standardize the endoscopic examination process. This narrative review provides an overview of AI principles and discusses the current knowledge on AI-assisted endoscopy in the context of screening colonoscopies. It highlights the significant role of AI in improving lesion detection, characterization, and quality assurance during colonoscopy. However, further well-designed studies are needed to validate the clinical impact and cost-effectiveness of AI-assisted colonoscopy before its widespread implementation.
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Affiliation(s)
- Marco Spadaccini
- Department of Endoscopy, Humanitas Research Hospital, IRCCS, 20089 Rozzano, Italy; Department of Biomedical Sciences, Humanitas University, 20089 Rozzano, Italy.
| | - Joel Troya
- Interventional and Experimental Endoscopy (InExEn), Department of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany
| | - Kareem Khalaf
- Division of Gastroenterology, St. Michael's Hospital, University of Toronto, Toronto, Canada
| | - Antonio Facciorusso
- Gastroenterology Unit, Department of Surgical and Medical Sciences, University of Foggia, Foggia, Italy
| | - Roberta Maselli
- Department of Endoscopy, Humanitas Research Hospital, IRCCS, 20089 Rozzano, Italy; Department of Biomedical Sciences, Humanitas University, 20089 Rozzano, Italy
| | - Alexander Hann
- Interventional and Experimental Endoscopy (InExEn), Department of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany
| | - Alessandro Repici
- Department of Endoscopy, Humanitas Research Hospital, IRCCS, 20089 Rozzano, Italy; Department of Biomedical Sciences, Humanitas University, 20089 Rozzano, Italy
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Desai M, Ausk K, Brannan D, Chhabra R, Chan W, Chiorean M, Gross SA, Girotra M, Haber G, Hogan RB, Jacob B, Jonnalagadda S, Iles-Shih L, Kumar N, Law J, Lee L, Lin O, Mizrahi M, Pacheco P, Parasa S, Phan J, Reeves V, Sethi A, Snell D, Underwood J, Venu N, Visrodia K, Wong A, Winn J, Wright CH, Sharma P. Use of a Novel Artificial Intelligence System Leads to the Detection of Significantly Higher Number of Adenomas During Screening and Surveillance Colonoscopy: Results From a Large, Prospective, US Multicenter, Randomized Clinical Trial. Am J Gastroenterol 2024; 119:1383-1391. [PMID: 38235741 DOI: 10.14309/ajg.0000000000002664] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/25/2023] [Accepted: 11/14/2023] [Indexed: 01/19/2024]
Abstract
INTRODUCTION Adenoma per colonoscopy (APC) has recently been proposed as a quality measure for colonoscopy. We evaluated the impact of a novel artificial intelligence (AI) system, compared with standard high-definition colonoscopy, for APC measurement. METHODS This was a US-based, multicenter, prospective randomized trial examining a novel AI detection system (EW10-EC02) that enables a real-time colorectal polyp detection enabled with the colonoscope (CAD-EYE). Eligible average-risk subjects (45 years or older) undergoing screening or surveillance colonoscopy were randomized to undergo either CAD-EYE-assisted colonoscopy (CAC) or conventional colonoscopy (CC). Modified intention-to-treat analysis was performed for all patients who completed colonoscopy with the primary outcome of APC. Secondary outcomes included positive predictive value (total number of adenomas divided by total polyps removed) and adenoma detection rate. RESULTS In modified intention-to-treat analysis, of 1,031 subjects (age: 59.1 ± 9.8 years; 49.9% male), 510 underwent CAC vs 523 underwent CC with no significant differences in age, gender, ethnicity, or colonoscopy indication between the 2 groups. CAC led to a significantly higher APC compared with CC: 0.99 ± 1.6 vs 0.85 ± 1.5, P = 0.02, incidence rate ratio 1.17 (1.03-1.33, P = 0.02) with no significant difference in the withdrawal time: 11.28 ± 4.59 minutes vs 10.8 ± 4.81 minutes; P = 0.11 between the 2 groups. Difference in positive predictive value of a polyp being an adenoma among CAC and CC was less than 10% threshold established: 48.6% vs 54%, 95% CI -9.56% to -1.48%. There were no significant differences in adenoma detection rate (46.9% vs 42.8%), advanced adenoma (6.5% vs 6.3%), sessile serrated lesion detection rate (12.9% vs 10.1%), and polyp detection rate (63.9% vs 59.3%) between the 2 groups. There was a higher polyp per colonoscopy with CAC compared with CC: 1.68 ± 2.1 vs 1.33 ± 1.8 (incidence rate ratio 1.27; 1.15-1.4; P < 0.01). DISCUSSION Use of a novel AI detection system showed to a significantly higher number of adenomas per colonoscopy compared with conventional high-definition colonoscopy without any increase in colonoscopy withdrawal time, thus supporting the use of AI-assisted colonoscopy to improve colonoscopy quality ( ClinicalTrials.gov NCT04979962).
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Affiliation(s)
- Madhav Desai
- Department of Gastroenterology, Kansas City VA Medical Center, Kansas City, Missouri, USA
| | - Karlee Ausk
- Gastroenterology, Swedish Health and Swedish Medical Center, Seattle, Washington, USA
| | - Donald Brannan
- Gastroenterology, Swedish Health and Swedish Medical Center, Seattle, Washington, USA
| | - Rajiv Chhabra
- Department of Gastroenterology, Saint Luke's Hospital of Kansas City, Kansas City, Missouri, USA
| | - Walter Chan
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Michael Chiorean
- Gastroenterology, Swedish Health and Swedish Medical Center, Seattle, Washington, USA
| | - Seth A Gross
- Gastroenterology, New York University Langone Health, New York, New York, USA
| | - Mohit Girotra
- Gastroenterology, Swedish Health and Swedish Medical Center, Seattle, Washington, USA
| | - Gregory Haber
- Gastroenterology, New York University Langone Health, New York, New York, USA
| | - Reed B Hogan
- GI Associates and Endoscopy Center, Jackson, Mississippi, USA
| | - Bobby Jacob
- Gastroenterology, Largo Medical Center, Largo, Florida, USA
| | - Sreeni Jonnalagadda
- Department of Gastroenterology, Saint Luke's Hospital of Kansas City, Kansas City, Missouri, USA
| | - Lulu Iles-Shih
- Gastroenterology, Swedish Health and Swedish Medical Center, Seattle, Washington, USA
| | - Navin Kumar
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Joanna Law
- Gastroenterology, Virginia Mason Franciscan Health, Seattle, Washington, USA
| | - Linda Lee
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Otto Lin
- Gastroenterology, Virginia Mason Franciscan Health, Seattle, Washington, USA
| | - Meir Mizrahi
- Gastroenterology, Largo Medical Center, Largo, Florida, USA
| | - Paulo Pacheco
- Gastroenterology, New York University Langone Health, New York, New York, USA
| | - Sravanthi Parasa
- Gastroenterology, Swedish Health and Swedish Medical Center, Seattle, Washington, USA
| | - Jennifer Phan
- Departement of Gastroenterology, Keck Medicine University of Southern California, Los Angeles, California, USA
| | - Vonda Reeves
- GI Associates and Endoscopy Center, Jackson, Mississippi, USA
| | - Amrita Sethi
- Department of Gastroenterology, Columbia University Irving Medical Center, New York, New York, USA
| | - David Snell
- Gastroenterology, New York University Langone Health, New York, New York, USA
| | - James Underwood
- GI Associates and Endoscopy Center, Jackson, Mississippi, USA
| | - Nanda Venu
- Gastroenterology, Virginia Mason Franciscan Health, Seattle, Washington, USA
| | - Kavel Visrodia
- Department of Gastroenterology, Columbia University Irving Medical Center, New York, New York, USA
| | - Alina Wong
- Gastroenterology, Swedish Health and Swedish Medical Center, Seattle, Washington, USA
| | - Jessica Winn
- Department of Gastroenterology, Kansas City VA Medical Center, Kansas City, Missouri, USA
| | | | - Prateek Sharma
- Department of Gastroenterology, Kansas City VA Medical Center, Kansas City, Missouri, USA
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20
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Chang YH, Shin CM, Lee HD, Park J, Jeon J, Cho SJ, Kang SJ, Chung JY, Jun YK, Choi Y, Yoon H, Park YS, Kim N, Lee DH. Real-World Application of Artificial Intelligence for Detecting Pathologic Gastric Atypia and Neoplastic Lesions. J Gastric Cancer 2024; 24:327-340. [PMID: 38960891 PMCID: PMC11224715 DOI: 10.5230/jgc.2024.24.e28] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2024] [Revised: 06/11/2024] [Accepted: 06/17/2024] [Indexed: 07/05/2024] Open
Abstract
PURPOSE Results of initial endoscopic biopsy of gastric lesions often differ from those of the final pathological diagnosis. We evaluated whether an artificial intelligence-based gastric lesion detection and diagnostic system, ENdoscopy as AI-powered Device Computer Aided Diagnosis for Gastroscopy (ENAD CAD-G), could reduce this discrepancy. MATERIALS AND METHODS We retrospectively collected 24,948 endoscopic images of early gastric cancers (EGCs), dysplasia, and benign lesions from 9,892 patients who underwent esophagogastroduodenoscopy between 2011 and 2021. The diagnostic performance of ENAD CAD-G was evaluated using the following real-world datasets: patients referred from community clinics with initial biopsy results of atypia (n=154), participants who underwent endoscopic resection for neoplasms (Internal video set, n=140), and participants who underwent endoscopy for screening or suspicion of gastric neoplasm referred from community clinics (External video set, n=296). RESULTS ENAD CAD-G classified the referred gastric lesions of atypia into EGC (accuracy, 82.47%; 95% confidence interval [CI], 76.46%-88.47%), dysplasia (88.31%; 83.24%-93.39%), and benign lesions (83.12%; 77.20%-89.03%). In the Internal video set, ENAD CAD-G identified dysplasia and EGC with diagnostic accuracies of 88.57% (95% CI, 83.30%-93.84%) and 91.43% (86.79%-96.07%), respectively, compared with an accuracy of 60.71% (52.62%-68.80%) for the initial biopsy results (P<0.001). In the External video set, ENAD CAD-G classified EGC, dysplasia, and benign lesions with diagnostic accuracies of 87.50% (83.73%-91.27%), 90.54% (87.21%-93.87%), and 88.85% (85.27%-92.44%), respectively. CONCLUSIONS ENAD CAD-G is superior to initial biopsy for the detection and diagnosis of gastric lesions that require endoscopic resection. ENAD CAD-G can assist community endoscopists in identifying gastric lesions that require endoscopic resection.
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Affiliation(s)
- Young Hoon Chang
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Cheol Min Shin
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
| | - Hae Dong Lee
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | | | | | - Soo-Jeong Cho
- Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
| | - Seung Joo Kang
- Department of Internal Medicine and Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National University Hospital, Seoul, Korea
| | - Jae-Yong Chung
- Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Yu Kyung Jun
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Yonghoon Choi
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Hyuk Yoon
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Young Soo Park
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Nayoung Kim
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
| | - Dong Ho Lee
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
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21
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Helderman NC, van Leerdam ME, Kloor M, Ahadova A, Nielsen M. Emerge of colorectal cancer in Lynch syndrome despite colonoscopy surveillance: A challenge of hide and seek. Crit Rev Oncol Hematol 2024; 197:104331. [PMID: 38521284 DOI: 10.1016/j.critrevonc.2024.104331] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/13/2024] [Revised: 03/09/2024] [Accepted: 03/20/2024] [Indexed: 03/25/2024] Open
Abstract
Even with colonoscopy surveillance, Lynch syndromes (LS) carriers still develop colorectal cancer (CRC). The cumulative incidence of CRCs under colonoscopy surveillance varies depending on the affected mismatch repair (MMR) gene. However, the precise mechanisms driving these epidemiological patterns remain incompletely understood. In recent years, several potential mechanisms explaining the occurrence of CRCs during colonoscopy surveillance have been proposed in individuals with and without LS. These encompass biological factors like concealed/accelerated carcinogenesis through a bypassed adenoma stage and accelerated progression from adenomas. Alongside these, various colonoscopy-related factors may contribute to formation of CRCs under colonoscopy surveillance, like missed yet detectable (pre)cancerous lesions, detected yet incompletely removed (pre)cancerous lesions, and colonoscopy-induced carcinogenesis due to tumor cell reimplantation. In this comprehensive literature update, we reviewed these potential factors and evaluated their relevance to each MMR group in an attempt to raise further awareness and stimulate research regarding this conflicting phenomenon.
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Affiliation(s)
- Noah C Helderman
- Department of Clinical Genetics, Leiden University Medical Center, Leiden, the Netherlands.
| | - Monique E van Leerdam
- Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, the Netherlands; Department of Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands
| | - Matthias Kloor
- Department of Applied Tumor Biology, Heidelberg University Hospital, Clinical Cooperation Unit Applied Tumor Biology, German Cancer Research Centre (DKFZ), Heidelberg, Germany
| | - Aysel Ahadova
- Department of Applied Tumor Biology, Heidelberg University Hospital, Clinical Cooperation Unit Applied Tumor Biology, German Cancer Research Centre (DKFZ), Heidelberg, Germany
| | - Maartje Nielsen
- Department of Clinical Genetics, Leiden University Medical Center, Leiden, the Netherlands
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22
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Han R, Acosta JN, Shakeri Z, Ioannidis JPA, Topol EJ, Rajpurkar P. Randomised controlled trials evaluating artificial intelligence in clinical practice: a scoping review. Lancet Digit Health 2024; 6:e367-e373. [PMID: 38670745 PMCID: PMC11068159 DOI: 10.1016/s2589-7500(24)00047-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/08/2023] [Revised: 03/01/2024] [Accepted: 03/04/2024] [Indexed: 04/28/2024]
Abstract
This scoping review of randomised controlled trials on artificial intelligence (AI) in clinical practice reveals an expanding interest in AI across clinical specialties and locations. The USA and China are leading in the number of trials, with a focus on deep learning systems for medical imaging, particularly in gastroenterology and radiology. A majority of trials (70 [81%] of 86) report positive primary endpoints, primarily related to diagnostic yield or performance; however, the predominance of single-centre trials, little demographic reporting, and varying reports of operational efficiency raise concerns about the generalisability and practicality of these results. Despite the promising outcomes, considering the likelihood of publication bias and the need for more comprehensive research including multicentre trials, diverse outcome measures, and improved reporting standards is crucial. Future AI trials should prioritise patient-relevant outcomes to fully understand AI's true effects and limitations in health care.
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Affiliation(s)
- Ryan Han
- Department of Biomedical Informatics, Harvard Medical School, Boston, MA, USA; Department of Computer Science, Stanford University, Stanford, CA, USA; University of California Los Angeles-Caltech Medical Scientist Training Program, Los Angeles, CA, USA
| | - Julián N Acosta
- Department of Neurology, Yale School of Medicine, New Haven, CT, USA; Rad AI, San Francisco, CA, USA
| | - Zahra Shakeri
- Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada
| | - John P A Ioannidis
- Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, USA; Meta-Research Innovation Center at Stanford, Stanford University, Stanford, CA, USA
| | - Eric J Topol
- Scripps Research Translational Institute, Scripps Research, La Jolla, CA, USA.
| | - Pranav Rajpurkar
- Department of Biomedical Informatics, Harvard Medical School, Boston, MA, USA
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23
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Patel HK, Mori Y, Hassan C, Rizkala T, Radadiya DK, Nathani P, Srinivasan S, Misawa M, Maselli R, Antonelli G, Spadaccini M, Facciorusso A, Khalaf K, Lanza D, Bonanno G, Rex DK, Repici A, Sharma P. Lack of Effectiveness of Computer Aided Detection for Colorectal Neoplasia: A Systematic Review and Meta-Analysis of Nonrandomized Studies. Clin Gastroenterol Hepatol 2024; 22:971-980.e15. [PMID: 38056803 DOI: 10.1016/j.cgh.2023.11.029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/28/2023] [Revised: 11/19/2023] [Accepted: 11/22/2023] [Indexed: 12/08/2023]
Abstract
BACKGROUND AND AIMS Benefits of computer-aided detection (CADe) in detecting colorectal neoplasia were shown in many randomized trials in which endoscopists' behavior was strictly controlled. However, the effect of CADe on endoscopists' performance in less-controlled setting is unclear. This systematic review and meta-analyses were aimed at clarifying benefits and harms of using CADe in real-world colonoscopy. METHODS We searched MEDLINE, EMBASE, Cochrane, and Google Scholar from inception to August 20, 2023. We included nonrandomized studies that compared the effectiveness between CADe-assisted and standard colonoscopy. Two investigators independently extracted study data and quality. Pairwise meta-analysis was performed utilizing risk ratio for dichotomous variables and mean difference (MD) for continuous variables with a 95% confidence interval (CI). RESULTS Eight studies were included, comprising 9782 patients (4569 with CADe and 5213 without CADe). Regarding benefits, there was a difference in neither adenoma detection rate (44% vs 38%; risk ratio, 1.11; 95% CI, 0.97 to 1.28) nor mean adenomas per colonoscopy (0.93 vs 0.79; MD, 0.14; 95% CI, -0.04 to 0.32) between CADe-assisted and standard colonoscopy, respectively. Regarding harms, there was no difference in the mean non-neoplastic lesions per colonoscopy (8 studies included for analysis; 0.52 vs 0.47; MD, 0.14; 95% CI, -0.07 to 0.34) and withdrawal time (6 studies included for analysis; 14.3 vs 13.4 minutes; MD, 0.8 minutes; 95% CI, -0.18 to 1.90). There was a substantial heterogeneity, and all outcomes were graded with a very low certainty of evidence. CONCLUSION CADe in colonoscopies neither improves the detection of colorectal neoplasia nor increases burden of colonoscopy in real-world, nonrandomized studies, questioning the generalizability of the results of randomized trials.
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Affiliation(s)
- Harsh K Patel
- Gastroenterology and Hepatology, University of Kansas Medical Center, Kansas City, Missouri
| | - Yuichi Mori
- Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway; Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan
| | - Cesare Hassan
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; Endoscopy Unit, IRCCS Humanitas Clinical and Research Center, Rozzano, Italy.
| | - Tommy Rizkala
- Endoscopy Unit, IRCCS Humanitas Clinical and Research Center, Rozzano, Italy
| | - Dhruvil K Radadiya
- Gastroenterology and Hepatology, University of Kansas Medical Center, Kansas City, Missouri
| | - Piyush Nathani
- Gastroenterology and Hepatology, University of Kansas Medical Center, Kansas City, Missouri
| | - Sachin Srinivasan
- Gastroenterology and Hepatology, University of Kansas Medical Center, Kansas City, Missouri
| | - Masashi Misawa
- Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan
| | - Roberta Maselli
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; Endoscopy Unit, IRCCS Humanitas Clinical and Research Center, Rozzano, Italy
| | - Giulio Antonelli
- Gastroenterology and Digestive Endoscopy Unit, Ospedale dei Castelli, Ariccia, Italy; Department of Anatomical, Histological, Forensic Medicine and Orthopedics Sciences, Sapienza University of Rome, Rome, Italy
| | - Marco Spadaccini
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; Endoscopy Unit, IRCCS Humanitas Clinical and Research Center, Rozzano, Italy
| | - Antonio Facciorusso
- Section of Gastroenterology, Department of Medical Sciences, University of Foggia, Foggia, Italy
| | - Kareem Khalaf
- Division of Gastroenterology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada
| | - Davide Lanza
- Gastroenterology and Hepatology, Clinica Moncucco, Lugano, Switzerland
| | - Giacomo Bonanno
- Endoscopy Unit, Humanitas Istituto Clinico Catanese, Catania, Italy
| | - Douglas K Rex
- Division of Gastroenterology, Indiana University School of Medicine, Indianapolis, Indiana
| | - Alessandro Repici
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; Endoscopy Unit, IRCCS Humanitas Clinical and Research Center, Rozzano, Italy
| | - Prateek Sharma
- Division of Gastroenterology, Indiana University School of Medicine, Indianapolis, Indiana; Gastroenterology and Hepatology, Kansas City VA Medical Center and University of Kansas School of Medicine, Kansas City, Missouri
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Lee MCM, Parker CH, Liu LWC, Farahvash A, Jeyalingam T. Impact of study design on adenoma detection in the evaluation of artificial intelligence-aided colonoscopy: a systematic review and meta-analysis. Gastrointest Endosc 2024; 99:676-687.e16. [PMID: 38272274 DOI: 10.1016/j.gie.2024.01.021] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/09/2023] [Revised: 12/19/2023] [Accepted: 01/10/2024] [Indexed: 01/27/2024]
Abstract
BACKGROUND AND AIMS Randomized controlled trials (RCTs) have reported that artificial intelligence (AI) improves endoscopic polyp detection. Different methodologies-namely, parallel and tandem designs-have been used to evaluate the efficacy of AI-assisted colonoscopy in RCTs. Systematic reviews and meta-analyses have reported a pooled effect that includes both study designs. However, it is unclear whether there are inconsistencies in the reported results of these 2 designs. Here, we aimed to determine whether study characteristics moderate between-trial differences in outcomes when evaluating the effectiveness of AI-assisted polyp detection. METHODS A systematic search of Ovid MEDLINE, Embase, Cochrane Central, Web of Science, and IEEE Xplore was performed through March 1, 2023, for RCTs comparing AI-assisted colonoscopy with routine high-definition colonoscopy in polyp detection. The primary outcome of interest was the impact of study type on the adenoma detection rate (ADR). Secondary outcomes included the impact of the study type on adenomas per colonoscopy and withdrawal time, as well as the impact of geographic location, AI system, and endoscopist experience on ADR. Pooled event analysis was performed using a random-effects model. RESULTS Twenty-four RCTs involving 17,413 colonoscopies (AI assisted: 8680; non-AI assisted: 8733) were included. AI-assisted colonoscopy improved overall ADR (risk ratio [RR], 1.24; 95% confidence interval [CI], 1.17-1.31; I2 = 53%; P < .001). Tandem studies collectively demonstrated improved ADR in AI-aided colonoscopies (RR, 1.18; 95% CI, 1.08-1.30; I2 = 0%; P < .001), as did parallel studies (RR, 1.26; 95% CI, 1.17-1.35; I2 = 62%; P < .001), with no statistical subgroup difference between study design. Both tandem and parallel study designs revealed improvement in adenomas per colonoscopy in AI-aided colonoscopies, but this improvement was more marked among tandem studies (P < .001). AI assistance significantly increased withdrawal times for parallel (P = .002), but not tandem, studies. ADR improvement was more marked among studies conducted in Asia compared to Europe and North America in a subgroup analysis (P = .007). Type of AI system used or endoscopist experience did not affect overall improvement in ADR. CONCLUSIONS Either parallel or tandem study design can capture the improvement in ADR resulting from the use of AI-assisted polyp detection systems. Tandem studies powered to detect differences in endoscopic performance through paired comparison may be a resource-efficient method of evaluating new AI-assisted technologies.
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Affiliation(s)
- Michelle C M Lee
- Division of Gastroenterology and Hepatology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada; Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Colleen H Parker
- Division of Gastroenterology and Hepatology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada; Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Louis W C Liu
- Division of Gastroenterology and Hepatology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada; Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Armin Farahvash
- Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Thurarshen Jeyalingam
- Division of Gastroenterology and Hepatology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada; Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
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Sridhar GR, Siva Prasad AV, Lakshmi G. Scope and caveats: Artificial intelligence in gastroenterology. Artif Intell Gastroenterol 2024; 5:91607. [DOI: 10.35712/aig.v5.i1.91607] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/23/2024] [Revised: 02/18/2024] [Accepted: 03/29/2024] [Indexed: 04/29/2024] Open
Abstract
The use of Artificial intelligence (AI) has evolved from its mid-20th century origins to playing a pivotal tool in modern medicine. It leverages digital data and computational hardware for diverse applications, including diagnosis, prognosis, and treatment responses in gastrointestinal and hepatic conditions. AI has had an impact in diagnostic techniques, particularly endoscopy, ultrasound, and histopathology. AI encompasses machine learning, natural language processing, and robotics, with machine learning being central. This involves sophisticated algorithms capable of managing complex datasets, far surpassing traditional statistical methods. These algorithms, both supervised and unsupervised, are integral for interpreting large datasets. In liver diseases, AI's non-invasive diagnostic applications, particularly in non-alcoholic fatty liver disease, and its role in characterizing hepatic lesions is promising. AI aids in distinguishing between normal and cirrhotic livers and improves the accuracy of lesion characterization and prognostication of hepatocellular carcinoma. AI enhances lesion identification during endoscopy, showing potential in the diagnosis and management of early-stage esophageal carcinoma. In peptic ulcer disease, AI technologies influence patient management strategies. AI is useful in colonoscopy, particularly in detecting smaller colonic polyps. However, its applicability in non-academic settings requires further validation. Addressing these issues is vital for harnessing the potential of AI. In conclusion, while AI offers transformative possibilities in gastroenterology, careful integration and balancing of technical possibilities with ethical and practical application, is essential for optimal use.
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Affiliation(s)
| | - Atmakuri V Siva Prasad
- Department of Gastroenterology, Institute of Gastroenterology, Visakhapatnam 530003, India
| | - Gumpeny Lakshmi
- Department of Internal Medicine, Gayatri Vidya Parishad Institute of Healthcare & Medical Technology, Visakhapatnam 530048, India
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Keswani RN, Thakkar U, Sals A, Pandolfino JE. A Computer-Aided Detection (CADe) System Significantly Improves Polyp Detection in Routine Practice. Clin Gastroenterol Hepatol 2024; 22:893-895.e1. [PMID: 37741303 DOI: 10.1016/j.cgh.2023.09.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/26/2023] [Revised: 09/08/2023] [Accepted: 09/08/2023] [Indexed: 09/25/2023]
Affiliation(s)
- Rajesh N Keswani
- Division of Gastroenterology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Digestive Health Center, Northwestern Medicine, Chicago, Illinois.
| | - Urvi Thakkar
- Digestive Health Center, Northwestern Medicine, Chicago, Illinois
| | - Alexandra Sals
- Digestive Health Center, Northwestern Medicine, Chicago, Illinois
| | - John E Pandolfino
- Division of Gastroenterology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Digestive Health Center, Northwestern Medicine, Chicago, Illinois
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Wei MT, Fay S, Yung D, Ladabaum U, Kopylov U. Artificial Intelligence-Assisted Colonoscopy in Real-World Clinical Practice: A Systematic Review and Meta-Analysis. Clin Transl Gastroenterol 2024; 15:e00671. [PMID: 38146871 PMCID: PMC10962886 DOI: 10.14309/ctg.0000000000000671] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/22/2023] [Accepted: 11/29/2023] [Indexed: 12/27/2023] Open
Abstract
INTRODUCTION Artificial intelligence (AI) could minimize the operator-dependent variation in colonoscopy quality. Computer-aided detection (CADe) has improved adenoma detection rate (ADR) and adenomas per colonoscopy (APC) in randomized controlled trials. There is a need to assess the impact of CADe in real-world settings. METHODS We searched MEDLINE, EMBASE, and Web of Science for nonrandomized real-world studies of CADe in colonoscopy. Random-effects meta-analyses were performed to examine the effect of CADe on ADR and APC. The study is registered under PROSPERO (CRD42023424037). There was no funding for this study. RESULTS Twelve of 1,314 studies met inclusion criteria. Overall, ADR was statistically significantly higher with vs without CADe (36.3% vs 35.8%, risk ratio [RR] 1.13, 95% confidence interval [CI] 1.01-1.28). This difference remained significant in subgroup analyses evaluating 6 prospective (37.3% vs 35.2%, RR 1.15, 95% CI 1.01-1.32) but not 6 retrospective (35.7% vs 36.2%, RR 1.12, 95% CI 0.92-1.36) studies. Among 6 studies with APC data, APC rate ratio with vs without CADe was 1.12 (95% CI 0.95-1.33). In 4 studies with GI Genius (Medtronic), there was no difference in ADR with vs without CADe (RR 0.96, 95% CI 0.85-1.07). DISCUSSION ADR, but not APC, was slightly higher with vs without CADe among all available real-world studies. This difference was attributed to the results of prospective but not retrospective studies. The discrepancies between these findings and those of randomized controlled trials call for future research on the true impact of current AI technology on colonoscopy quality and the subtleties of human-AI interactions.
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Affiliation(s)
- Mike Tzuhen Wei
- Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California, USA
| | - Shmuel Fay
- Department of Gastroenterology, Sheba Medical Center, Ramat Gan, Israel
- Tel Aviv University Medical School, Tel Aviv, Israel
| | - Diana Yung
- Gold Coast Hospital and Health Service, Gold Coast, Australia.
| | - Uri Ladabaum
- Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California, USA
| | - Uri Kopylov
- Department of Gastroenterology, Sheba Medical Center, Ramat Gan, Israel
- Tel Aviv University Medical School, Tel Aviv, Israel
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Wei MT, Chen Y, Quan SY, Pan JY, Wong RJ, Friedland S. Evaluation of computer aided detection during colonoscopy among Veterans: Randomized clinical trial. Artif Intell Med Imaging 2023; 4:1-9. [DOI: 10.35711/aimi.v4.i1.1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/23/2023] [Revised: 10/10/2023] [Accepted: 10/30/2023] [Indexed: 12/05/2023] Open
Abstract
BACKGROUND There has been significant interest in use of computer aided detection (CADe) devices in colonoscopy to improve polyp detection and reduce miss rate.
AIM To investigate the use of CADe amongst veterans.
METHODS Between September 2020 and December 2021, we performed a randomized controlled trial to evaluate the impact of CADe. Patients at Veterans Affairs Palo Alto Health Care System presenting for screening or low-risk surveillance were randomized to colonoscopy performed with or without CADe. Primary outcomes of interest included adenoma detection rate (ADR), adenomas per colonoscopy (APC), and adenomas per extraction. In addition, we measured serrated polyps per colonoscopy, non-adenomatous, non-serrated polyps per colonoscopy, serrated polyp detection rate, and procedural time.
RESULTS A total of 244 patients were enrolled (124 with CADe), with similar patient characteristics (age, sex, body mass index, indication) between the two groups. Use of CADe was found to have decreased number of adenomas (1.79 vs 2.53, P = 0.030) per colonoscopy compared to without CADe. There was no significant difference in number of serrated polyps or non-adenomatous non-serrated polyps per colonoscopy between the two groups. Overall, use of CADe was found to have lower ADR (68.5% vs 80.0%, P = 0.041) compared to without use of CADe. Serrated polyp detection rate was lower with CADe (3.2% vs 7.5%) compared to without CADe, but this was not statistically significant (P = 0.137). There was no significant difference in withdrawal and procedure times between the two groups or in detection of adenomas per extraction (71.4% vs 73.1%, P = 0.613). No adverse events were identified.
CONCLUSION While several randomized controlled trials have demonstrated improved ADR and APC with use of CADe, in this RCT performed at a center with high ADR, use of CADe was found to have decreased APC and ADR. Further studies are needed to understand the true impact of CADe on performance quality among endoscopists as well as determine criteria for endoscopists to consider when choosing to adopt CADe in their practices.
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Affiliation(s)
- Mike T Wei
- Department of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, CA 94305, United States
| | - Yu Chen
- Department of Gastroenterology and Hepatology, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94305, United States
| | - Susan Y Quan
- Department of Gastroenterology and Hepatology, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94305, United States
| | - Jennifer Y Pan
- Department of Gastroenterology and Hepatology, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94305, United States
| | - Robert J Wong
- Department of Gastroenterology and Hepatology, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94305, United States
| | - Shai Friedland
- Department of Gastroenterology and Hepatology, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94305, United States
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Goetz N, Hanigan K, Cheng RKY. Artificial intelligence fails to improve colonoscopy quality: A single centre retrospective cohort study. Artif Intell Gastrointest Endosc 2023; 4:18-26. [DOI: 10.37126/aige.v4.i2.18] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/04/2023] [Revised: 11/07/2023] [Accepted: 11/30/2023] [Indexed: 12/07/2023] Open
Abstract
BACKGROUND Limited data currently exists on the clinical utility of Artificial Intelligence Assisted Colonoscopy (AIAC) outside of clinical trials.
AIM To evaluate the impact of AIAC on key markers of colonoscopy quality compared to conventional colonoscopy (CC).
METHODS This single-centre retrospective observational cohort study included all patients undergoing colonoscopy at a secondary centre in Brisbane, Australia. CC outcomes between October 2021 and October 2022 were compared with AIAC outcomes after the introduction of the Olympus Endo-AID module from October 2022 to January 2023. Endoscopists who conducted over 50 procedures before and after AIAC introduction were included. Procedures for surveillance of inflammatory bowel disease were excluded. Patient demographics, proceduralist specialisation, indication for colonoscopy, and colonoscopy quality metrics were collected. Adenoma detection rate (ADR) and sessile serrated lesion detection rate (SSLDR) were calculated for both AIAC and CC.
RESULTS The study included 746 AIAC procedures and 2162 CC procedures performed by seven endoscopists. Baseline patient demographics were similar, with median age of 60 years with a slight female predominance (52.1%). Procedure indications, bowel preparation quality, and caecal intubation rates were comparable between groups. AIAC had a slightly longer withdrawal time compared to CC, but the difference was not statistically significant. The introduction of AIAC did not significantly change ADR (52.1% for AIAC vs 52.6% for CC, P = 0.91) or SSLDR (17.4% for AIAC vs 18.1% for CC, P = 0.44).
CONCLUSION The implementation of AIAC failed to improve key markers of colonoscopy quality, including ADR, SSLDR and withdrawal time. Further research is required to assess the utility and cost-efficiency of AIAC for high performing endoscopists.
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Affiliation(s)
- Naeman Goetz
- Department of Gastroenterology, Redcliffe Hospital, Redcliffe 4020, Australia
| | - Katherine Hanigan
- Department of Gastroenterology, Redcliffe Hospital, Redcliffe 4020, Australia
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Lou S, Du F, Song W, Xia Y, Yue X, Yang D, Cui B, Liu Y, Han P. Artificial intelligence for colorectal neoplasia detection during colonoscopy: a systematic review and meta-analysis of randomized clinical trials. EClinicalMedicine 2023; 66:102341. [PMID: 38078195 PMCID: PMC10698672 DOI: 10.1016/j.eclinm.2023.102341] [Citation(s) in RCA: 20] [Impact Index Per Article: 10.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/01/2023] [Revised: 11/14/2023] [Accepted: 11/15/2023] [Indexed: 05/11/2024] Open
Abstract
BACKGROUND The use of artificial intelligence (AI) in detecting colorectal neoplasia during colonoscopy holds the potential to enhance adenoma detection rates (ADRs) and reduce adenoma miss rates (AMRs). However, varied outcomes have been observed across studies. Thus, this study aimed to evaluate the potential advantages and disadvantages of employing AI-aided systems during colonoscopy. METHODS Using Medical Subject Headings (MeSH) terms and keywords, a comprehensive electronic literature search was performed of the Embase, Medline, and the Cochrane Library databases from the inception of each database until October 04, 2023, in order to identify randomized controlled trials (RCTs) comparing AI-assisted with standard colonoscopy for detecting colorectal neoplasia. Primary outcomes included AMR, ADR, and adenomas detected per colonoscopy (APC). Secondary outcomes comprised the poly missed detection rate (PMR), poly detection rate (PDR), and poly detected per colonoscopy (PPC). We utilized random-effects meta-analyses with Hartung-Knapp adjustment to consolidate results. The prediction interval (PI) and I2 statistics were utilized to quantify between-study heterogeneity. Moreover, meta-regression and subgroup analyses were performed to investigate the potential sources of heterogeneity. This systematic review and meta-analysis is registered with PROSPERO (CRD42023428658). FINDINGS This study encompassed 33 trials involving 27,404 patients. Those undergoing AI-aided colonoscopy experienced a significant decrease in PMR (RR, 0.475; 95% CI, 0.294-0.768; I2 = 87.49%) and AMR (RR, 0.495; 95% CI, 0.390-0.627; I2 = 48.76%). Additionally, a significant increase in PDR (RR, 1.238; 95% CI, 1.158-1.323; I2 = 81.67%) and ADR (RR, 1.242; 95% CI, 1.159-1.332; I2 = 78.87%), along with a significant increase in the rates of PPC (IRR, 1.388; 95% CI, 1.270-1.517; I2 = 91.99%) and APC (IRR, 1.390; 95% CI, 1.277-1.513; I2 = 86.24%), was observed. This resulted in 0.271 more PPCs (95% CI, 0.144-0.259; I2 = 65.61%) and 0.202 more APCs (95% CI, 0.144-0.259; I2 = 68.15%). INTERPRETATION AI-aided colonoscopy significantly enhanced the detection of colorectal neoplasia detection, likely by reducing the miss rate. However, future studies should focus on evaluating the cost-effectiveness and long-term benefits of AI-aided colonoscopy in reducing cancer incidence. FUNDING This work was supported by the Heilongjiang Provincial Natural Science Foundation of China (LH2023H096), the Postdoctoral research project in Heilongjiang Province (LBH-Z22210), the National Natural Science Foundation of China's General Program (82072640) and the Outstanding Youth Project of Heilongjiang Natural Science Foundation (YQ2021H023).
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Affiliation(s)
- Shenghan Lou
- Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, No.150 Haping Road, Harbin, Heilongjiang, 150081, China
| | - Fenqi Du
- Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, No.150 Haping Road, Harbin, Heilongjiang, 150081, China
| | - Wenjie Song
- Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, No.150 Haping Road, Harbin, Heilongjiang, 150081, China
| | - Yixiu Xia
- Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, No.150 Haping Road, Harbin, Heilongjiang, 150081, China
| | - Xinyu Yue
- Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, No.150 Haping Road, Harbin, Heilongjiang, 150081, China
| | - Da Yang
- Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, No.150 Haping Road, Harbin, Heilongjiang, 150081, China
| | - Binbin Cui
- Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, No.150 Haping Road, Harbin, Heilongjiang, 150081, China
| | - Yanlong Liu
- Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, No.150 Haping Road, Harbin, Heilongjiang, 150081, China
| | - Peng Han
- Department of Colorectal Surgery, Harbin Medical University Cancer Hospital, No.150 Haping Road, Harbin, Heilongjiang, 150081, China
- Key Laboratory of Tumor Immunology in Heilongjiang, No.150 Haping Road, Harbin, Heilongjiang, 150081, China
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Hsu WF, Chiu HM. Optimization of colonoscopy quality: Comprehensive review of the literature and future perspectives. Dig Endosc 2023; 35:822-834. [PMID: 37381701 DOI: 10.1111/den.14627] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/14/2023] [Accepted: 06/27/2023] [Indexed: 06/30/2023]
Abstract
Colonoscopy is crucial in preventing colorectal cancer (CRC) and reducing associated mortality. This comprehensive review examines the importance of high-quality colonoscopy and associated quality indicators, including bowel preparation, cecal intubation rate, withdrawal time, adenoma detection rate (ADR), complete resection, specimen retrieval, complication rates, and patient satisfaction, while also discussing other ADR-related metrics. Additionally, the review draws attention to often overlooked quality aspects, such as nonpolypoid lesion detection, as well as insertion and withdrawal skills. Moreover, it explores the potential of artificial intelligence in enhancing colonoscopy quality and highlights specific considerations for organized screening programs. The review also emphasizes the implications of organized screening programs and the need for continuous quality improvement. A high-quality colonoscopy is crucial for preventing postcolonoscopy CRC- and CRC-related deaths. Health-care professionals must develop a thorough understanding of colonoscopy quality components, including technical quality, patient safety, and patient experience. By prioritizing ongoing evaluation and refinement of these quality indicators, health-care providers can contribute to improved patient outcomes and develop more effective CRC screening programs.
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Affiliation(s)
- Wen-Feng Hsu
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
| | - Han-Mo Chiu
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
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Young E, Edwards L, Singh R. The Role of Artificial Intelligence in Colorectal Cancer Screening: Lesion Detection and Lesion Characterization. Cancers (Basel) 2023; 15:5126. [PMID: 37958301 PMCID: PMC10647850 DOI: 10.3390/cancers15215126] [Citation(s) in RCA: 8] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/12/2023] [Revised: 10/14/2023] [Accepted: 10/14/2023] [Indexed: 11/15/2023] Open
Abstract
Colorectal cancer remains a leading cause of cancer-related morbidity and mortality worldwide, despite the widespread uptake of population surveillance strategies. This is in part due to the persistent development of 'interval colorectal cancers', where patients develop colorectal cancer despite appropriate surveillance intervals, implying pre-malignant polyps were not resected at a prior colonoscopy. Multiple techniques have been developed to improve the sensitivity and accuracy of lesion detection and characterisation in an effort to improve the efficacy of colorectal cancer screening, thereby reducing the incidence of interval colorectal cancers. This article presents a comprehensive review of the transformative role of artificial intelligence (AI), which has recently emerged as one such solution for improving the quality of screening and surveillance colonoscopy. Firstly, AI-driven algorithms demonstrate remarkable potential in addressing the challenge of overlooked polyps, particularly polyp subtypes infamous for escaping human detection because of their inconspicuous appearance. Secondly, AI empowers gastroenterologists without exhaustive training in advanced mucosal imaging to characterise polyps with accuracy similar to that of expert interventionalists, reducing the dependence on pathologic evaluation and guiding appropriate resection techniques or referrals for more complex resections. AI in colonoscopy holds the potential to advance the detection and characterisation of polyps, addressing current limitations and improving patient outcomes. The integration of AI technologies into routine colonoscopy represents a promising step towards more effective colorectal cancer screening and prevention.
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Affiliation(s)
- Edward Young
- Faculty of Health and Medical Sciences, University of Adelaide, Lyell McEwin Hospital, Haydown Rd, Elizabeth Vale, SA 5112, Australia
| | - Louisa Edwards
- Faculty of Health and Medical Sciences, University of Adelaide, Queen Elizabeth Hospital, Port Rd, Woodville South, SA 5011, Australia
| | - Rajvinder Singh
- Faculty of Health and Medical Sciences, University of Adelaide, Lyell McEwin Hospital, Haydown Rd, Elizabeth Vale, SA 5112, Australia
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Berzin TM, Glissen Brown J. Navigating the "Trough of Disillusionment" for CADe Polyp Detection: What Can We Learn About Negative AI Trials and the Physician-AI Hybrid? Am J Gastroenterol 2023; 118:1743-1745. [PMID: 37141122 DOI: 10.14309/ajg.0000000000002286] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/24/2023] [Accepted: 03/27/2023] [Indexed: 05/05/2023]
Affiliation(s)
- Tyler M Berzin
- Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA
| | - Jeremy Glissen Brown
- Division of Gastroenterology, Duke University Medical Center, Durham, North Carolina, USA
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Hassan C, Spadaccini M, Mori Y, Foroutan F, Facciorusso A, Gkolfakis P, Tziatzios G, Triantafyllou K, Antonelli G, Khalaf K, Rizkala T, Vandvik PO, Fugazza A, Rondonotti E, Glissen-Brown JR, Kamba S, Maida M, Correale L, Bhandari P, Jover R, Sharma P, Rex DK, Repici A. Real-Time Computer-Aided Detection of Colorectal Neoplasia During Colonoscopy : A Systematic Review and Meta-analysis. Ann Intern Med 2023; 176:1209-1220. [PMID: 37639719 DOI: 10.7326/m22-3678] [Citation(s) in RCA: 74] [Impact Index Per Article: 37.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 08/31/2023] Open
Abstract
BACKGROUND Artificial intelligence computer-aided detection (CADe) of colorectal neoplasia during colonoscopy may increase adenoma detection rates (ADRs) and reduce adenoma miss rates, but it may increase overdiagnosis and overtreatment of nonneoplastic polyps. PURPOSE To quantify the benefits and harms of CADe in randomized trials. DESIGN Systematic review and meta-analysis. (PROSPERO: CRD42022293181). DATA SOURCES Medline, Embase, and Scopus databases through February 2023. STUDY SELECTION Randomized trials comparing CADe-assisted with standard colonoscopy for polyp and cancer detection. DATA EXTRACTION Adenoma detection rate (proportion of patients with ≥1 adenoma), number of adenomas detected per colonoscopy, advanced adenoma (≥10 mm with high-grade dysplasia and villous histology), number of serrated lesions per colonoscopy, and adenoma miss rate were extracted as benefit outcomes. Number of polypectomies for nonneoplastic lesions and withdrawal time were extracted as harm outcomes. For each outcome, studies were pooled using a random-effects model. Certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. DATA SYNTHESIS Twenty-one randomized trials on 18 232 patients were included. The ADR was higher in the CADe group than in the standard colonoscopy group (44.0% vs. 35.9%; relative risk, 1.24 [95% CI, 1.16 to 1.33]; low-certainty evidence), corresponding to a 55% (risk ratio, 0.45 [CI, 0.35 to 0.58]) relative reduction in miss rate (moderate-certainty evidence). More nonneoplastic polyps were removed in the CADe than the standard group (0.52 vs. 0.34 per colonoscopy; mean difference [MD], 0.18 polypectomy [CI, 0.11 to 0.26 polypectomy]; low-certainty evidence). Mean inspection time increased only marginally with CADe (MD, 0.47 minute [CI, 0.23 to 0.72 minute]; moderate-certainty evidence). LIMITATIONS This review focused on surrogates of patient-important outcomes. Most patients, however, may consider cancer incidence and cancer-related mortality important outcomes. The effect of CADe on such patient-important outcomes remains unclear. CONCLUSION The use of CADe for polyp detection during colonoscopy results in increased detection of adenomas but not advanced adenomas and in higher rates of unnecessary removal of nonneoplastic polyps. PRIMARY FUNDING SOURCE European Commission Horizon 2020 Marie Skłodowska-Curie Individual Fellowship.
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Affiliation(s)
- Cesare Hassan
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, and Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy (C.H., M.S., A.R.)
| | - Marco Spadaccini
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, and Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy (C.H., M.S., A.R.)
| | - Yuichi Mori
- Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway, and Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan (Y.M.)
| | - Farid Foroutan
- Ted Rogers Centre for Heart Research, University Health Network, Toronto, Ontario, Canada (F.F.)
| | - Antonio Facciorusso
- Department of Medical Sciences, Section of Gastroenterology, University of Foggia, Foggia, Italy (A.Facciorusso)
| | - Paraskevas Gkolfakis
- Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium (P.G.)
| | - Georgios Tziatzios
- Hepatogastroenterology Unit, Second Department of Internal Medicine-Propaedeutic, Medical School, National and Kapodistrian University of Athens, Attikon University General Hospital, Athens, Greece (G.T., K.T.)
| | - Konstantinos Triantafyllou
- Hepatogastroenterology Unit, Second Department of Internal Medicine-Propaedeutic, Medical School, National and Kapodistrian University of Athens, Attikon University General Hospital, Athens, Greece (G.T., K.T.)
| | - Giulio Antonelli
- Gastroenterology and Digestive Endoscopy Unit, Ospedale dei Castelli, Ariccia, and Department of Anatomical, Histological, Forensic Medicine and Orthopedics Sciences, Sapienza University of Rome, Rome, Italy (G.A.)
| | - Kareem Khalaf
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy (K.K., T.R.)
| | - Tommy Rizkala
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy (K.K., T.R.)
| | - Per Olav Vandvik
- Department of Medicine, Lovisenberg Diaconal Hospital, Oslo, Norway (P.O.V.)
| | - Alessandro Fugazza
- Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy (A.Fugazza, L.C.)
| | | | - Jeremy R Glissen-Brown
- Center for Advanced Endoscopy, Division of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts (J.R.G.)
| | - Shunsuke Kamba
- Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan (S.K.)
| | - Marcello Maida
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy (M.M.)
| | - Loredana Correale
- Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy (A.Fugazza, L.C.)
| | - Pradeep Bhandari
- Department of Gastroenterology, Queen Alexandra Hospital, Portsmouth, United Kingdom (P.B.)
| | - Rodrigo Jover
- Departamento de Medicina Clínica, Servicio de Gastroenterología, Hospital General Universitario Dr. Balmis, Instituto de Investigación Biomédica de Alicante ISABIAL, Universidad Miguel Hernández, Alicante, Spain (R.J.)
| | - Prateek Sharma
- Gastroenterology and Hepatology, Kansas City VA Medical Center, Kansas City, Missouri (P.S.)
| | - Douglas K Rex
- Division of Gastroenterology, Indiana University School of Medicine, Indianapolis, Indiana (D.K.R.)
| | - Alessandro Repici
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, and Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy (C.H., M.S., A.R.)
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35
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Karsenti D, Tharsis G, Perrot B, Cattan P, Percie du Sert A, Venezia F, Zrihen E, Gillet A, Lab JP, Tordjman G, Cavicchi M. Effect of real-time computer-aided detection of colorectal adenoma in routine colonoscopy (COLO-GENIUS): a single-centre randomised controlled trial. Lancet Gastroenterol Hepatol 2023; 8:726-734. [PMID: 37269872 DOI: 10.1016/s2468-1253(23)00104-8] [Citation(s) in RCA: 24] [Impact Index Per Article: 12.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/03/2023] [Revised: 04/03/2023] [Accepted: 04/06/2023] [Indexed: 06/05/2023]
Abstract
BACKGROUND Artificial intelligence systems have been developed to improve polyp detection. We aimed to evaluate the effect of real-time computer-aided detection (CADe) on the adenoma detection rate (ADR) in routine colonoscopy. METHODS This single-centre randomised controlled trial (COLO-GENIUS) was done at the Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France. All consecutive individuals aged 18 years or older who were scheduled for a total colonoscopy and had an American Society of Anesthesiologists score of 1-3 were screened for inclusion. After the caecum was reached and the colonic preparation was appropriate, eligible participants were randomly assigned (1:1; computer-generated random numbers list) to either standard colonoscopy or CADe-assisted colonoscopy (GI Genius 2.0.2; Medtronic). Participants and cytopathologists were masked to study assignment, whereas endoscopists were not. The primary outcome was ADR, which was assessed in the modified intention-to-treat population (all randomly assigned participants except those with misplaced consent forms). Safety was analysed in all included patients. According to statistical calculations, 20 endoscopists from the Clinique Paris-Bercy had to include approximately 2100 participants with 1:1 randomisation. The trial is complete and registered with ClinicalTrials.gov, NCT04440865. FINDINGS Between May 1, 2021, and May 1, 2022, 2592 participants were assessed for eligibility, of whom 2039 were randomly assigned to standard colonoscopy (n=1026) or CADe-assisted colonoscopy (n=1013). 14 participants in the standard group and ten participants in the CADe group were then excluded due to misplaced consent forms, leaving 2015 participants (979 [48·6%] men and 1036 [51·4%] women) in the modified intention-to-treat analysis. ADR was 33·7% (341 of 1012 colonoscopies) in the standard group and 37·5% (376 of 1003 colonoscopies) in the CADe group (estimated mean absolute difference 4·1 percentage points [95% CI 0·0-8·1]; p=0·051). One bleeding event without deglobulisation occurred in the CADe group after a large (>2 cm) polyp resection and resolved after a haemostasis clip was placed during a second colonoscopy. INTERPRETATION Our findings support the benefits of CADe, even in a non-academic centre. Systematic use of CADe in routine colonoscopy should be considered. FUNDING None.
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Affiliation(s)
- David Karsenti
- Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France.
| | - Gaëlle Tharsis
- Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France
| | - Bastien Perrot
- UMR 1246 SPHERE, INSERM, Nantes University and Tours University, Nantes, France
| | - Philippe Cattan
- Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France
| | - Alice Percie du Sert
- Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France
| | - Franck Venezia
- Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France
| | - Elie Zrihen
- Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France
| | - Agnès Gillet
- Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France
| | | | - Gilles Tordjman
- Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France
| | - Maryan Cavicchi
- Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France
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