Randomized Controlled Trial
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Jul 27, 2024; 16(7): 2270-2280
Published online Jul 27, 2024. doi: 10.4240/wjgs.v16.i7.2270
Effectiveness of colonoscopy, immune fecal occult blood testing, and risk-graded screening strategies in colorectal cancer screening
Ming Xu, Jing-Yi Yang, Tao Meng
Ming Xu, Tao Meng, Department of Colorectal Surgery, Qilu Hospital (Qingdao), Cheeloo College of Medicine, Qingdao 266000, Shandong Province, China
Jing-Yi Yang, Department of Gastrointestinal Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, Henan Province, China
Author contributions: Xu M wrote the manuscript; Yang JY collected the data; Meng T guided the study. All authors reviewed, edited, and approved the final manuscript and revised it critically for important intellectual content, gave final approval of the version to be published, and agreed to be accountable for all aspects of the work.
Institutional review board statement: This study was approved by the Medical Ethics Committee of The First Affiliated Hospital of Zhengzhou University.
Clinical trial registration statement: This study is a national multicenter RCT of colorectal cancer screening in the population [TARGET-C study, Chinese Clinical Trial Platform (http://www.chitr.org.cn)].
Informed consent statement: Informed consent was obtained from all the patients for this study.
Conflict-of-interest statement: The authors declare no conflicts of interest for this article.
Data sharing statement: The data in this study support the principles of transparent science, and the corresponding data sets can be shared with the scientific community upon reasonable request. For detailed data access and usage rules, please contact the person in charge of this study: jingyi_yang1613@163.com.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Tao Meng, Doctor, Department of Colorectal Surgery, Qilu Hospital (Qingdao), Cheeloo College of Medicine, No. 758 Hefei Road, Qingdao 266000, Shandong Province, China. 18561810550@163.com
Received: February 14, 2024
Revised: May 15, 2024
Accepted: May 27, 2024
Published online: July 27, 2024
Processing time: 158 Days and 19.1 Hours
Abstract
BACKGROUND

Colorectal cancer (CRC) is one of the most common malignant tumors, and early screening is crucial to improving the survival rate of patients. The combination of colonoscopy and immune fecal occult blood detection has garnered significant attention as a novel method for CRC screening. Colonoscopy and fecal occult blood tests, when combined, can improve screening accuracy and early detection rates, thereby facilitating early intervention and treatment. However, certain risks and costs accompany it, making the establishment of a risk classification model crucial for accurate classification and management of screened subjects.

AIM

To evaluate the feasibility and effectiveness of colonoscopy, immune fecal occult blood test (FIT), and risk-graded screening strategies in CRC screening.

METHODS

Based on the randomized controlled trial of CRC screening in the population conducted by our hospital May 2020 to May 2023, participants who met the requirements were randomly assigned to a colonoscopy group, an FIT group, or a graded screening group at a ratio of 1:2:2 (after risk assessment, the high-risk group received colonoscopy, the low-risk group received an FIT test, and the FIT-positive group received colonoscopy). The three groups received CRC screening with different protocols, among which the colonoscopy group only received baseline screening, and the FIT group and the graded screening group received annual follow-up screening based on baseline screening. The primary outcome was the detection rate of advanced tumors, including CRC and advanced adenoma. The population participation rate, advanced tumor detection rate, and colonoscopy load of the three screening programs were compared.

RESULTS

A total of 19373 subjects who met the inclusion and exclusion criteria were enrolled, including 8082 males (41.7%) and 11291 females (58.3%). The mean age was 60.05 ± 6.5 years. Among them, 3883 patients were enrolled in the colonoscopy group, 7793 in the FIT group, and 7697 in the graded screening group. Two rounds of follow-up screening were completed in the FIT group and the graded screening group. The graded screening group (89.2%) and the colonoscopy group (42.3%) had the lowest overall screening participation rates, while the FIT group had the highest (99.3%). The results of the intentional analysis showed that the detection rate of advanced tumors in the colonoscopy group was greater than that of the FIT group [2.76% vs 2.17%, odds ratio (OR) = 1.30, 95% confidence interval (CI): 1.01-1.65, P = 0.037]. There was no significant difference in the detection rate of advanced tumors between the colonoscopy group and the graded screening group (2.76% vs 2.35%, OR = 1.9, 95%CI: 0.93-1.51, P = 0.156), as well as between the graded screening group and the FIT group (2.35% vs 2.17%, OR = 1.09%, 95%CI: 0.88-1.34, P = 0.440). The number of colonoscopy examinations required for each patient with advanced tumors was used as an index to evaluate the colonoscopy load during population screening. The graded screening group had the highest colonoscopy load (15.4 times), followed by the colonoscopy group (10.2 times), and the FIT group had the lowest (7.8 times).

CONCLUSION

A hierarchical screening strategy based on CRC risk assessment is feasible for screening for CRC in the population. It can be used as an effective supplement to traditional colonoscopy and FIT screening programs.

Keywords: Colorectal tumor; Immune fecal occult blood testing; Colonoscopy; Hierarchical screening; Risk assessment

Core Tip: A multicenter randomized controlled trial was conducted to investigate the role of colonoscopy combined with immune fecal occult blood test in colorectal cancer screening and establish a risk classification model. The efficacy and safety of the screening methods were evaluated by comparing the colorectal cancer detection rate, early diagnosis rate, and adverse event rate of the screening group and the control group. At the same time, the collected data were used to construct risk classification models for different risk groups, so as to realize individual screening management of subjects.