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Loganathan P, Gajendran M, Perisetti A, Goyal H, Mann R, Wright R, Saligram S, Thosani N, Umapathy C. Endoscopic Advances in the Diagnosis and Management of Gastroesophageal Reflux Disease. MEDICINA (KAUNAS, LITHUANIA) 2024; 60:1120. [PMID: 39064549 PMCID: PMC11278532 DOI: 10.3390/medicina60071120] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/07/2024] [Revised: 07/01/2024] [Accepted: 07/09/2024] [Indexed: 07/28/2024]
Abstract
Gastroesophageal reflux disease (GERD) is one of the most common diseases that occurs secondary to failure of the antireflux barrier system, resulting in the frequent and abnormal reflux of gastric contents to the esophagus. GERD is diagnosed in routine clinical practice based on the classic symptoms of heartburn and regurgitation. However, a subset of patients with atypical symptoms can pose challenges in diagnosing GERD. An esophagogastroduodenoscopy (EGD) is the most common initial diagnostic test used in the assessment for GERD, although half of these patients will not have any positive endoscopic findings suggestive of GERD. The advanced endoscopic techniques have improved the diagnostic yield of GERD diagnosis and its complications, such as Barrett's esophagus and early esophageal adenocarcinoma. These newer endoscopic tools can better detect subtle irregularities in the mucosa and vascular structures. The management options for GERD include lifestyle modifications, pharmacological therapy, and endoscopic and surgical interventions. The latest addition to the armamentarium is the minimally invasive endoscopic interventions in carefully selected patients, including the electrical stimulation of the LES, Antireflux mucosectomy, Radiofrequency therapy, Transoral Incisionless Fundoplication, Endoscopic Full-Thickness plication (GERDx™), and suturing devices. With the emergence of these advanced endoscopic techniques, it is crucial to understand their selection criteria, advantages, and disadvantages.
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Affiliation(s)
- Priyadarshini Loganathan
- Division of Gastroenterology & Nutrition, The University of Texas Health Science Center San Antonio, San Antonio, TX 78229, USA; (P.L.); (M.G.); (R.W.)
| | - Mahesh Gajendran
- Division of Gastroenterology & Nutrition, The University of Texas Health Science Center San Antonio, San Antonio, TX 78229, USA; (P.L.); (M.G.); (R.W.)
| | - Abhilash Perisetti
- Department of Gastroenterology and Hepatology, Kansas City VA Medical Center, Kansas City, MO 64128, USA;
| | - Hemant Goyal
- Department of Gastroenterology, Borland Groover, Baptist Medical Center-Downtown, Jacksonville, FL 32207, USA
| | - Rupinder Mann
- Department of Gastroenterology, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA;
| | - Randy Wright
- Division of Gastroenterology & Nutrition, The University of Texas Health Science Center San Antonio, San Antonio, TX 78229, USA; (P.L.); (M.G.); (R.W.)
| | - Shreyas Saligram
- Department of Gastroenterology, Robert Wood Johnson University Hospital, New Brunswick, NJ 08901, USA;
| | - Nirav Thosani
- Department of Surgery, McGovern Medical School at UT Health, Houston, TX 77030, USA;
| | - Chandraprakash Umapathy
- Division of Gastroenterology & Nutrition, Audie L. Murphy VA Hospital, San Antonio, TX 78229, USA;
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Harwani Y, Butala S, More B, Shukla V, Patel A. Endoscopic full-thickness plication along with argon plasma coagulation for treatment of proton pump inhibitor dependent gastroesophageal reflux disease. World J Gastrointest Endosc 2024; 16:250-258. [PMID: 38813575 PMCID: PMC11130550 DOI: 10.4253/wjge.v16.i5.250] [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: 01/13/2024] [Revised: 02/28/2024] [Accepted: 04/25/2024] [Indexed: 05/14/2024] Open
Abstract
BACKGROUND Most endoscopic anti-reflux interventions for gastroesophageal reflux disease (GERD) management are technically challenging to practice with inadequate data to support it utility. Therefore, this study was carried to evaluate the effectiveness and safety newer endoscopic full-thickness fundoplication (EFTP) device along with Argon Plasma Coagulation to treat individuals with GERD. AIM To evaluate the effectiveness and safety newer EFTP device along with Argon Plasma Coagulation to treat individuals with GERD. METHODS This study was a single-center comparative analysis conducted on patients treated at a Noble Institute of Gastroenterology, Ahmedabad, hospital between 2020 and 2022. The research aimed to retrospectively analyze patient data on GERD symptoms and proton pump inhibitor (PPI) dependence who underwent EFTP using the GERD-X system along with argon plasma coagulation (APC). The primary endpoint was the mean change in the total gastroesophageal reflux disease health-related quality of life (GERD-HRQL) score compared to the baseline measurement at the 3-month follow-up. Secondary endpoints encompassed enhancements in the overall GERD-HRQL score, improvements in GERD symptom scores at the 3 and changes in PPI usage at the 3 and 12-month time points. RESULTS In this study, patients most were in Hill Class II, and over half had ineffective esophageal motility. Following the EFTP procedure, there were significant improvements in heartburn and regurgitation scores, as well as GERD-HRQL scores (P < 0.001). PPI use significantly decreased, with 82.6% not needing PPIs or prokinetics at end of 1 year. No significant adverse events related to the procedures were observed in either group. CONCLUSION The EFTP along with APC procedure shows promise in addressing GERD symptoms and improving patients' quality of life, particularly for suitable candidates. Moreover, the application of a lone clip with APC yielded superior outcomes and exhibited greater cost-effectiveness.
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Affiliation(s)
- Yogesh Harwani
- Department of Gastroenterology, Nobel Gastro Hospital, Ahmedabad 408409, Gujarat, India
| | - Shreya Butala
- Department of Gastroenterology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow 226014, Uttar Pradesh, India
| | - Balaji More
- Department of Pharmacology, Mahatma Gandhi Medical College and Research Institute, Puducherry 607402, Puducherry, India
| | - Varun Shukla
- Department of Gastroenterology, Noble Institute of Gastroenterology, Ahmedabad 380009, Gujrat, India
| | - Anand Patel
- Department of Gastroenterology, Noble Institute of Gastroenterology, Ahmedabad 380009, Gujrat, India
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Maydeo A, Patil G, Kamat N, Dalal A, Vadgaonkar A, Parekh S, Daftary R, Vora S. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux after peroral endoscopic myotomy: a randomized sham-controlled study. Endoscopy 2023; 55:689-698. [PMID: 36944359 PMCID: PMC10374353 DOI: 10.1055/a-2040-4042] [Citation(s) in RCA: 13] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2022] [Accepted: 02/01/2023] [Indexed: 03/23/2023]
Abstract
BACKGROUND : Endoscopic full-thickness plication (EFTP) has shown promising results in gastroesophageal reflux disease (GERD), but its efficacy in GERD after peroral endoscopic myotomy (POEM) is unclear. METHODS : In a prospective, randomized trial of post-POEM patients dependent on proton pump inhibitors (PPIs) for documented GERD, patients underwent EFTP (plication to remodel the gastroesophageal flap valve) or an endoscopic sham procedure (positioning of the EFTP device, but no stapling). The primary end point was improvement in acid exposure time (AET) < 6 % (3 months). Secondary end points included improvement in esophagitis (3 months), GERD Questionnaire (GERDQ) score (3 and 6 months), and PPI usage (6 months). RESULTS : 60 patients were randomized (30 in each group). At 3 months, a significantly higher proportion of patients achieved improvement in AET < 6 % in the EFTP group compared with the sham group (69.0 % [95 %CI 52.1-85.8] vs. 10.3 % [95 %CI 0-21.4], respectively). EFTP was statistically superior to sham (within-group analysis) in improving esophageal AET, DeMeester Score, and all reflux episodes (P < 0.001). A nonsignificant improvement in esophagitis was noted in the EFTP group (P = 0.14). Median GERDQ scores (3 months) were significantly better (P < 0.001) in the EFTP group, and the same trend continued at 6 months. A higher proportion of patients in the sham group continued to use PPIs (72.4 % [95 %CI 56.1-88.7] vs. 27.6 % [95 %CI 11.3-43.8]). There were no major adverse events in either group. CONCLUSION : EFTP improved post-POEM GERD symptoms, 24-hour pH impedance findings with normalization in one-third, and reduced PPI usage at 6 months.
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Affiliation(s)
- Amit Maydeo
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Gaurav Patil
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Nagesh Kamat
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Ankit Dalal
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Amol Vadgaonkar
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Sanil Parekh
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Rajen Daftary
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Sehajad Vora
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
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Abstract
The last decade has seen the rise of multiple novel endoscopic techniques to treat gastroesophageal reflux disease, many of which are efficacious when compared with traditional surgical options and allow relief from long-term dependence on antacid medications. This review will explore the latest endoscopic treatment options for gastroesophageal reflux disease including a description of the technique, review of efficacy and safety, and future directions.
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Affiliation(s)
- Rodrigo Duarte Chavez
- Department of Gastroenterology, Robert Wood Johnson Medical Center, New Brunswick, NJ
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Kalapala R, Karyampudi A, Nabi Z, Darisetty S, Jagtap N, Ramchandani M, Gupta R, Lakhtakia S, Goud R, Venkat Rao G, Sharma P, Reddy DN. Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial. Gut 2022; 71:686-694. [PMID: 33849942 PMCID: PMC8921577 DOI: 10.1136/gutjnl-2020-321811] [Citation(s) in RCA: 22] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/13/2020] [Revised: 03/30/2021] [Accepted: 04/01/2021] [Indexed: 12/17/2022]
Abstract
BACKGROUND The majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD. DESIGN Patients with proton pump inhibitor (PPI)-dependent GERD were randomised to either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months. RESULTS Seventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29-42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). The mean (±SD) duration of EFTP procedure was 17.4 (±4) min. The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 (60.9-100.0) versus 8.0 (2.2-21.6); p<0.001) and 12 (92.3 (84.4-100.0) versus 9.1 (4.8-36.0); p<0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major procedure-related adverse events were encountered in either group. CONCLUSION EFTP using a novel device is safe and effective in improving quality of life in patients with PPI dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate. TRIAL REGISTRATION NUMBER NCT03322553.
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Affiliation(s)
- Rakesh Kalapala
- Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
| | - Arun Karyampudi
- Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
| | - Zaheer Nabi
- Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
| | - Santosh Darisetty
- Anaesthesia, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
| | - Nitin Jagtap
- Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India
| | - Mohan Ramchandani
- Gastroenterology, Asian Institute of Gastroenetrology, Hyderabad, Andhra Pradesh, India
| | - Rajesh Gupta
- Asian Institute of Gatroenterology, Hyderabad, India
| | - Sundeep Lakhtakia
- Gastroenterology, Asian Institute of Gastroenetrology, Hyderabad, Andhra Pradesh, India
| | - Rajesh Goud
- Asian Institute of Gastroenterology, Hyderabad, Telangana, India
| | - G Venkat Rao
- Surgical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India
| | | | - D Nageshwar Reddy
- Asian Healthcare Foundation, Asian Institute of Gastroenterology, Hyderabad, Andhra Pradesh, India
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Evaluation of Antireflux Mucosectomy for Severe Gastroesophageal Reflux Disease: Medium-Term Results of a Pilot Study. Gastroenterol Res Pract 2022; 2022:1606944. [PMID: 35237316 PMCID: PMC8885295 DOI: 10.1155/2022/1606944] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/24/2021] [Accepted: 01/31/2022] [Indexed: 11/24/2022] Open
Abstract
Background Antireflux mucosectomy, a new endoscopic treatment for gastroesophageal reflux disease, consists of endoscopic mucosal resection at the esophagogastric junction. This study aim was to evaluate the medium-term efficacy of the antireflux mucosectomy technique for patients with severe gastroesophageal reflux disease symptoms (proton pump inhibitor treatment-dependent or proton pump inhibitor treatment-resistant gastroesophageal reflux disease). Methods Between January 2017 and June 2018, 13 patients with severe gastroesophageal reflux disease without hiatal hernia, with positive pH reflux, were included in this monocentric prospective pilot study. The primary outcome was clinical success, defined by improvement evaluated by the Gastroesophageal Reflux Disease Health Related Quality of Life Questionnaire at 24 months. Secondary outcomes were technical success, decreased use of proton pump inhibitors, patient satisfaction, and adverse events. Results Thirteen patients [females = 8 (62%)], mean age 59 (range, 54-68), were included. The antireflux mucosectomy procedure had technical success in all patients. At 24 months, for 11 patients, gastroesophageal reflux disease symptoms were significantly improved, and mean gastroesophageal reflux disease score decreased from 33 (range, 26-42) to 3 (range, 0-7) (p = 0.001). Ninety-one percent (n = 10) of patients had a lower proton pump inhibitor intake at 24 months. One patient had 3 endoscopic balloon dilatations for EGJ stenosis, two patients had melena ten days after procedure, and seven patients had thoracic or abdominal pain. Patient's satisfaction at 24 months was 81%. Conclusions In patients with severe gastroesophageal reflux disease, despite occurrence of several short-term adverse events, antireflux mucosectomy seemed effective in improving gastroesophageal reflux disease symptoms at 24 months. This trial is registered with ClinicalTrials: NCT03357809.
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Mann R, Gajendran M, Perisetti A, Goyal H, Saligram S, Umapathy C. Advanced Endoscopic Imaging and Interventions in GERD: An Update and Future Directions. Front Med (Lausanne) 2021; 8:728696. [PMID: 34912815 PMCID: PMC8666712 DOI: 10.3389/fmed.2021.728696] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/21/2021] [Accepted: 10/29/2021] [Indexed: 12/12/2022] Open
Abstract
Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal diseases encountered in primary care and gastroenterology clinics. Most cases of GERD can be diagnosed based on clinical presentation and risk factors; however, some patients present with atypical symptoms, which can make diagnosis difficult. An esophagogastroduodenoscopy can be used to assist in diagnosis of GERD, though only half of these patients have visible endoscopic findings on standard white light endoscopy. This led to the development of new advanced endoscopic techniques that enhanced the diagnosis of GERD and related complications like squamous cell dysplasia, Barrett's esophagus, and early esophageal adenocarcinoma. This is conducted by improved detection of subtle irregularities in the mucosa and vascular structures through optical biopsies in real-time. Management of GERD includes lifestyle modifications, pharmacological therapy, endoscopic and surgical intervention. Minimally invasive endoscopic intervention can be an option in selected patients with small hiatal hernia and without complications of GERD. These endoscopic interventions include endoscopic fundoplication, endoscopic mucosal resection techniques, ablative techniques, creating mechanical barriers, and suturing and stapling devices. As these new advanced endoscopic techniques are emerging, data surrounding the indications, advantages and disadvantages of these techniques need a thorough understanding.
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Affiliation(s)
- Rupinder Mann
- Department of Internal Medicine, Saint Agnes Medical Center, Fresno, CA, United States
| | - Mahesh Gajendran
- Paul L. Foster School of Medicine, Texas Tech University Health Sciences Center, El Paso, TX, United States
| | - Abhilash Perisetti
- Department of Gastroenterology and Hepatology, The University of Arkansas for Medical Sciences, Little Rock, AR, United States.,Department of Gastroenterology and Advanced Endoscopy, Parkview Health, Fort Wayne, IN, United States
| | - Hemant Goyal
- The Wright Center for Graduate Medical Education, Scranton, PA, United States
| | - Shreyas Saligram
- Division of Gastroenterology, Long School of Medicine, University of Texas Health San Antonio, San Antonio, TX, United States
| | - Chandraprakash Umapathy
- Division of Gastroenterology, Long School of Medicine, University of Texas Health San Antonio, San Antonio, TX, United States
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Vaezi MF, Shaheen NJ, Muthusamy VR. State of Evidence in Minimally Invasive Management of Gastroesophageal Reflux: Findings of a Scoping Review. Gastroenterology 2020; 159:1504-1525. [PMID: 32621903 DOI: 10.1053/j.gastro.2020.05.097] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/28/2020] [Revised: 04/30/2020] [Accepted: 05/11/2020] [Indexed: 12/13/2022]
Abstract
BACKGROUNDS & AIMS Endoscopic management of gastroesophageal reflux disease (GERD) is being employed increasingly. The aim of this scoping review was to assess the volume of available evidence on the benefits of endoscopic and minimally invasive surgical therapies for GERD. METHODS criteria were used to perform an extensive literature search of data regarding the reported benefit of endoscopic therapies in GERD. Randomized controlled studies were utilized when available; however, data from observational studies were also reviewed. RESULTS A formal review of evidence was performed in 22 studies. Inclusion and exclusion criteria and study duration were noted and tabulated. Assessment of outcomes was based on symptoms and objective criteria reported by investigators. Reported outcomes for the interventions were tabulated under the heading of subjective (symptom scores, quality of life metrics, and change in proton pump inhibitor use) and objective metrics (pH parameters, endoscopic signs, and lower esophageal sphincter pressure changes). Adverse events were noted and tabulated. The majority of studies showed symptomatic and objective improvement of GERD with the device therapies. Adverse events were minimal. However, normalization of acid exposure occurred in about 50% of patients and, for some modalities, long-term durability is uncertain. CONCLUSIONS This scoping review revealed that the endoluminal and minimally invasive surgical devices for GERD therapy are a promising alternative to proton pump inhibitor therapy. Their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially durability of effect, are better understood.
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Affiliation(s)
- Michael F Vaezi
- Division of Gastroenterology, Hepatology, and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee.
| | - Nicholas J Shaheen
- Division of Gastroenterology, Hepatology, and Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - V Raman Muthusamy
- Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California
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De Moura EGH, Sallum RAA, Nasi A, Coronel M, De Moura DTH, De Moura ETH, Minata MK, Cury M, Falcão A, Cecconello I, Sakai P. Endoscopic polymer injection and endoluminal plication in treatment of gastroesophageal reflux disease: evaluation of long-term results. Endosc Int Open 2018; 6:E630-E636. [PMID: 29756023 PMCID: PMC5943693 DOI: 10.1055/a-0573-1194] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/31/2017] [Accepted: 01/03/2018] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND AND STUDY AIMS Us of proton pump inhibitors (PPIs) has made endoscopic treatment of gastroesophageal reflux disease (GERD) more efficient, with reduction in morbidity and complications. However, some patients persist with symptoms despite medical treatment and some are not compliant with it or cannot afford it for financial reasons, and thus they require non-pharmacological therapeutic options such as surgical fundoplication. Surgery may be effective in the short term, but there is related morbidity and concern about its long-term efficacy. The possibility of minimally invasive endoluminal surgeries has resulted in interest in and development of newly endoscopic devices. Good short-term results with surgical fundoplication lack of studies of is with long follow-up justify our interest in this study. The aim of this study was to investigate the efficacy of endoscopic polymer injection and endoluminal full-thickness plication in the long-term control of GERD. PATIENTS AND METHODS Forty-seven patients with GERD who underwent an endoscopic procedure were followed up for 60 months and evaluated for total response (RT), partial response (RP) and no response (SR) to endoscopic treatment with reintroduction of PPIs. RESULTS Twenty-one patients received polymer injection (G0) and 26 endoluminal plication (G1). The number of patients with no response to endoscopic treatment with reintroduction of PPIs increased in time for both techniques (G0 P = 0.006; G1 P < 0.001). There was symptomatic improvement up to 12 months, with progressive loss of this trending up to 60 months in G0 and G1 ( P < 0.001). Health-related quality of life score (GERD-HRQL) demonstrated TR in G0 and G1 at 1, 3, 6 and 12 months. The 60-month analysis showed an increased number of patients with SR in both groups. The quality of life assessment (SF-36) showed benefit in G0 up to 3 months. G0 showed a higher rate of complications. There were no deaths. There was healing of esophagitis at 3 months in 45 % of patients in G0 and 40 % in G1. There was no improvement in manometric or pH findings. CONCLUSION Endoscopic therapies were ineffective in controlling GERD in the long term.
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Affiliation(s)
| | - Rubens A. A. Sallum
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Ary Nasi
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Martin Coronel
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil,Corresponding author Martin Coronel Universidade de São Paulo Faculdade de MedicinaGastrointestinal EndoscopyAv. Dr Enéas de Carvalho Aguiar 225
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andar, bloco 3
Cerqueira Cezar ZIP Code 05403-010São Paulo, SP, Brazil+55-112-661-6467
| | - Diogo Turiani Hourneaux De Moura
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | | | - Mauricio Kazuyoshi Minata
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Marcelo Cury
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Angela Falcão
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Ivan Cecconello
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Paulo Sakai
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
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Ellsmere J, Jones D, Pleskow D, Chuttani R. Endoluminal Instrumentation Is Changing Gastrointestinal Surgery. Surg Innov 2016; 13:145-51. [PMID: 17012156 DOI: 10.1177/1553350606291470] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Advances in endoluminal instrumentation and technology are enabling endoscopists to perform increasingly sophisticated procedures. Indications for these procedures are likely to expand as outcomes studies show they are efficacious and cost-effective. This article highlights several recent advances in endoluminal suturing, dissecting, and ligating and discusses the impact of these advances on the practice of gastrointestinal surgery. Endoluminal suturing offers select patients with gastroesophageal reflux disease a safe and effective alternative to laparoscopic surgery. Devices designed for endoluminal hemostasis and endoscopic mucosal resection can be used effectively for a broader range of applications and are already being used to perform transluminal surgery in animal models; human trials are forthcoming. Gastrointestinal surgeons should support efforts to critically evaluate endoluminal techniques because they have an opportunity to improve care. Surgical residents planning careers in gastrointestinal surgery need to understand endoscopic techniques and consider their training opportunities.
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Affiliation(s)
- James Ellsmere
- Section of Minimally Invasive Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, USA.
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Endoluminal flexible endoscopic suturing for minimally invasive therapies. Gastrointest Endosc 2015; 81:262-9.e19. [PMID: 25440675 DOI: 10.1016/j.gie.2014.09.013] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/24/2014] [Accepted: 09/03/2014] [Indexed: 12/12/2022]
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Antireflux endoluminal therapies: past and present. Gastroenterol Res Pract 2013; 2013:481417. [PMID: 23935608 PMCID: PMC3723090 DOI: 10.1155/2013/481417] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/18/2013] [Accepted: 06/13/2013] [Indexed: 12/14/2022] Open
Abstract
The basic principle of antireflux procedures employing endoscopic intervention aims to create a mechanical barrier to prevent primary pathophysiology in gastroesophageal reflux disease (GERD). We review, highlight, and discuss the past and present status of endoluminal therapy. Currently, there are 3 commonly employed anti-reflux endoluminal procedures: fundoplication or suturing techniques (EndoCinch, NDO, and EsophyX), intramural injection or implant techniques (enhancing lower esophageal sphincter (LES) volume and/or strengthening compliance of the LES-Enteryx and Gatekeeper), and radiofrequency ablation of LES and cardia. EndoCinch plication requires further study and modification of technique before it can be recommended because of durability issues. Esophynx, the transoral incisionless fundoplication, may reduce hiatal hernias and increase LES length. Preliminary studies have shown promising reduction in symptoms and medication use but evidence concerning safety and long-term durability is still pending. The safety issue with injection technique is the main concern as evident from the incidences of implant withdrawals after reported major adverse events. Future research with cautious monitoring is required before any new implant material can be recommended for commercial application. Radiofrequency ablation therapy is regaining popularity in treating refractory symptoms despite PPI use due to improved efficacy, durability, and safety after years of refinement of protocol.
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Pauli EM, Delaney CP, Champagne B, Stein S, Marks JM. Safety and effectiveness of an endoscopic suturing device in a human colonic treat-and-resect model. Surg Innov 2013; 20:594-9. [PMID: 23445712 DOI: 10.1177/1553350613479204] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND Despite advances in many areas of therapeutic endoscopy, the development of an effective endoscopic suturing device has been elusive. The purpose of this trial was to evaluate the safety and effectiveness of a suturing device to place and secure sutures within normal, in vivo human colonic tissue prior to surgical resection. METHODS Patients undergoing elective colectomy were enrolled in this treat-and-resect model. The Overstitch endoscopic suturing device (Apollo Endosurgery, Austin, TX) was used to place sutures in healthy colonic tissue during a 15-minute, time-limited period. Following colectomy, the explanted tissue was evaluated to determine the depth of suture penetration and the effectiveness of the suture/cinch element. Clinical and operative data were recorded. RESULTS Four patients (50% female) were enrolled. Seven sutures were successfully placed, incorporating a total of 10 tissue bites in a mean of 13.5 minutes. On inspection of the explanted tissue, all sutures were found to be located subserosal (no full thickness bites were taken). The suture and cinch elements were judged to be effective in the majority of cases. One device-related issue did not inhibit the ability to oppose tissue or place the cinch. There were no intraoperative or postoperative complications. CONCLUSIONS The Overstitch permitted safe and effective suturing in an in vivo human colon model. The sutures were placed at a consistent subserosal depth and at no point risked iatrogenic injury to adjacent structures. Technical issues with the device were infrequent and did not inhibit the ability to place sutures effectively.
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Affiliation(s)
- Eric M Pauli
- 1University Hospitals Case Medical Center, Cleveland, OH
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Légner A, Tsuboi K, Stadlhuber R, Yano F, Halvax P, Hunt B, Penka W, Filipi CJ. Mucosal excision and suturing for obesity and GERD. Surg Innov 2013; 20:586-93. [PMID: 23423723 DOI: 10.1177/1553350613475881] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND Suture and staple-based endoluminal devices for gastroesophageal reflux disease (GERD) and obesity have failed to demonstrate long-term efficacy. OBJECTIVE To demonstrate the feasibility of mucosal excision and full-thickness suture apposition of the excision beds to create sufficient scar tissue formation at the gastroesophageal junction for the intraluminal treatment of GERD or obesity. DESIGN Survival animal experiments. PATIENTS Seven mongrel dogs. Interventions. Under general endotracheal anesthesia, a Barostat test was performed on 4 dogs. A mucosal excision device was introduced through the esophagus into the proximal stomach. Two to 4 mucosal excisions were performed on all dogs at or just below the gastroesophageal junction and the mucosal pieces were removed. After hemostasis, an intraluminal suturing instrument was introduced and either 2 or 4 sutures were placed through the excision beds to bring them into apposition. These were tied and the suture strands cut. All dogs were survived for 2 months. End-term endoscopies were performed, and a repeat Barostat procedure was performed on the animals undergoing an antireflux procedure. After euthanasia the stomachs were explanted, examined, photographed, and sectioned for histologic examination. RESULTS All dogs survived without complication. In the 4 GERD dogs, the Barostat studies demonstrated a significant decrease in gastroesophageal junction compliance. In the 3 dogs undergoing the obesity procedure, the gastric outlet apposition to a 6-mm endoscope was satisfactory with full insufflation and the desired scarring was seen on histologic examination. CONCLUSION It is possible to create adequate gastroesophageal junction scarring for the treatment of GERD and obesity. A clinical pilot study will be initiated.
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Affiliation(s)
- András Légner
- 1Creighton University School of Medicine, Omaha, NE, USA
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Endoscopic radiofrequency versus a sham procedure for treatment of gastroesophageal reflux disease. EGYPTIAN LIVER JOURNAL 2011. [DOI: 10.1097/01.elx.0000397026.33294.5f] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022] Open
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Zagol B, Mikami D. Advances in transoral fundoplication for oesophageal reflux. Dig Liver Dis 2011; 43:361-4. [PMID: 21382755 DOI: 10.1016/j.dld.2011.01.006] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/19/2010] [Accepted: 01/04/2011] [Indexed: 12/11/2022]
Abstract
BACKGROUND The purpose of this review was to evaluate transoral fundoplication devices for gastro-oesophageal reflux disease that have been commercially available within the last 5 years. METHODS Literature databases including Medline and Pubmed were searched from January 2005 to November 2010. Both blinded and unblinded randomized studies were evaluated. RESULTS We reviewed the literature for evaluations of primary transoral endoluminal fundoplication devices which included EndoCinch, NDO Plicator, Esophyx, and Stretta. Reviews of all studies with greater than 20 patients were evaluated to assess the efficacy and safety of transoral fundoplication devices. These endoluminal devices were primary matched against sham procedures. The EndoCinch and Stretta procedures were the only devices compared to laparoscopic fundoplication, the current standard for surgical management of gastro-oesophageal reflux disease. CONCLUSION The field of endoluminal treatment of gastro-oesophageal reflux disease has gained popularity over the last several years. Endoluminal treatment of gastro-oesophageal reflux disease has been shown to be safe and effective in recent studies. We still believe more randomized prospective studies need to be carried out to determine if endoluminal therapies will be a durable option for patients with gastro-oesophageal reflux disease. Continuing research will further the advancement of endoluminal gastro-oesophageal reflux disease procedures in the future.
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Affiliation(s)
- Bradley Zagol
- Division of General Surgery, The Ohio State University Hospitals, Columbus, OH, United States
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Calisto JL, Kawamura J, Trencheva K, Oliveira O, Ho V, Yan J, Lei W, Milsom J. Fixation of intestinal tissue using a novel endoscopic device. Surg Innov 2010; 18:44-7. [PMID: 21193479 DOI: 10.1177/1553350610388670] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
INTRODUCTION The purpose of this study was to assess the utility and strength of a novel endoscopic fixation device, Brace-Bar, in the large intestine and compare the strength with other currently available techniques. The primary outcome was the strength of fixation using 3 endoscopic methods: BraceBar, suture, and commercially available tackers. The hypothesis is that the use of the BraceBar will result in fixation strength similar to the strength of the other methods. MATERIALS AND METHODS An ex vivo porcine model was used to test 3 fixation methods: Group 1, BraceBar (Prototype); Group 2, ProTack (AutoSuture); and Group 3, TI-CRON suture (Syneture). Large-bowel segments were fixed to abdominal wall tissue at 20 cm from the distal end of the rectum. Primary endpoint was pull away strength. A total of 45 trials of each method were performed. Comparison between the groups was done using JMP 7.0. RESULTS There was no significant difference in strength between the BraceBar group and the suture group ( P = .1236). The BraceBar method demonstrated significantly higher strength compared with the tacker group (P = .003). CONCLUSION Use of the BraceBar for fixation of the large bowel is at least comparable with suture fixation, making clinical use of BraceBar a reasonable consideration. Use of this device may make endoscopic repair of certain intestinal conditions feasible.
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Affiliation(s)
- Juan Luis Calisto
- Department of Colon and Rectal Surgery, Weill Cornell Medical College, New York, NY, USA.
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Khajanchee YS, Ujiki M, Dunst CM, Swanstrom LL. Patient factors predictive of 24-h pH normalization following endoluminal gastroplication for GERD. Surg Endosc 2009; 23:2525-30. [PMID: 19430838 DOI: 10.1007/s00464-009-0448-9] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/25/2008] [Revised: 02/17/2009] [Accepted: 02/27/2009] [Indexed: 12/17/2022]
Abstract
BACKGROUND Endoluminal full-thickness gastroplication has been documented to provide significant and long-lasting improvement of GERD symptoms and health-related quality of life (HRQL) with very little patient morbidity. These treatments, however, are criticized for normalizing esophageal acid exposure in only 30-40% of patients treated. We hypothesize that there are objective criteria that will identify those patients who will have a normal DeMeester score (DMS) following endoluminal treatment. METHODS Data from a prospective multicenter trial using the NDO Plicator device to treat GERD were available for statistical analysis. All patients were treated with endoluminal full-thickness gastroplication. All patients had GERD symptoms and abnormal 24-h pH exposure preoperatively. Postoperative objective outcome was assessed by performing 24-h pH studies at 6 months. Univariate and multivariate regression analyses were performed to determine factors predictive of successful treatment (normalized 24-h pH). RESULTS A total of 266 patients were included in the study. Mean preoperative DMS was 47.91 (+/-31.34). Postoperatively, mean DMS decreased significantly (37.11 +/- 24.63, p < 0.001), and 31.67% of patients had a DMS within normal range (DMS < 22). Results of multivariate regression analysis demonstrated that the following preoperative patient characteristics were predictive of postoperative success (normal DMS): DMS < 30 (odds ratio [OR] = 4.24, 95% confidence interval [CI] = 1.73, 10.36, p < 0.001), heartburn score < 2 (OR = 3.37, CI = 1.44, 7.89, p = 0.005), and BMI < 30 (OR = 4.93, CI = 1.55, 15.61, p = 0.007). CONCLUSION Data analysis from this prospective study indicates that the odds of objective success would be significantly greater if the treatment was restricted to thinner patients with mild reflux disease. This may help define the optimal place for endoluminal therapy in a comprehensive GERD treatment algorithm.
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Affiliation(s)
- Yashodhan S Khajanchee
- Minimally Invasive Surgery Program, Legacy Health System, 1040 NW 22nd Ave., Suite 560, Portland, OR 97210, USA.
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Chen D, Barber C, McLoughlin P, Thavaneswaran P, Jamieson GG, Maddern GJ. Systematic review of endoscopic treatments for gastro-oesophageal reflux disease. Br J Surg 2009; 96:128-36. [PMID: 19160349 DOI: 10.1002/bjs.6440] [Citation(s) in RCA: 46] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND The aim of this review was to assess the safety and efficacy of endoscopic procedures for gastro-oesophageal reflux disease. METHODS Literature databases including Medline, Embase and PubMed were searched up to May 2006 without language restriction. Randomized controlled trials and non-randomized comparative studies with at least ten patients in each study arm, and case series studies of at least ten patients, were included. RESULTS A total of 33 studies examining seven endoscopic procedures (Stretta procedure, Bard EndoCinch, Wilson-Cook Endoscopic Suturing Device, NDO Plicator, Enteryx, Gatekeeper Reflux Repair System and Plexiglas) were included in the review. Of the three procedures that were tested against sham controls (Stretta procedure, Bard EndoCinch and Enteryx), patient outcomes in the treatment group were either as good as, or significantly better than, those of control patients in terms of heartburn symptoms, quality of life and medication usage. However, for the two procedures that were tested against laparoscopic fundoplication (Stretta) procedure and Bard EndoCinch), outcomes for patients in the endoscopic group were either as good as, or inferior to, those for the laparoscopic group. CONCLUSION At present there is insufficient evidence to determine the safety and efficacy of endoscopic procedures for gastro-oesophageal reflux disease, particularly in the long term.
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Affiliation(s)
- D Chen
- Department of Surgery, University of Adelaide and The Queen Elizabeth Hospital, South Australia, Australia
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Transoral endoscopic fundoplication in the treatment of gastroesophageal reflux disease: the anatomic and physiologic basis for reconstruction of the esophagogastric junction using a novel device. Ann Surg 2008; 248:69-76. [PMID: 18580209 DOI: 10.1097/sla.0b013e31817c9630] [Citation(s) in RCA: 53] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
OBJECTIVE To determine the safety, mechanism of action, immediate postprocedural anatomic impact on the esophagogastric junction, and short-term efficacy of the first entirely endolumenal antireflux procedure. BACKGROUND A safe and effective endoscopic antireflux procedure remains elusive. Transoral endolumenal surgery has enormous potential for the treatment of gastroesophageal reflux disease (GERD) and other esophagogastric diseases. A canine model was used to study a novel endoscopic device, which allows for creation of an endoluminal fundoplication. METHODS The transoral incisionless fundoplication (TIF) was performed in 21 canines in a phase I feasibility and safety study, and in 21 canines in a phase II study that included a detailed objective assessment of the effects of 2 variants of the TIF procedure (TIF 1.0 and TIF 2.0) versus sham on esophageal physiology and esophagogastric junction (EGJ) anatomy. RESULTS In phase I, TIF provided a safe and feasible endolumenal therapy for GERD, with histologic data that demonstrated serosal fusion of approximated full-thickness tissue plications and durability of the fundoplication. TIF procedures effectively reduced cardia circumference and improved Hill classification grade. In phase II, the TIF 2.0 procedure achieved normalization of distal esophageal acid exposure and increased lower esophageal sphincter (LES) pressure and length based on objective testing over a 2-week period. TIF 2.0 demonstrated superior results to TIF 1.0, and valve appearance and location exhibited similarity to the Nissen fundoplication by vector volume analysis. CONCLUSIONS The TIF procedure is safe and results in a durable and functional fundoplication as well as a platform for further development and modification of the procedure, which can be use to impact outcome. This work provides the foundation for human translation and assessment of long-term outcomes.
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Dolan JP, Downey DM, Sheppard BC, Fennerty MB, Hunter JG. Evaluation of endoscopic full-thickness plication on anti-reflux valve competency. JOURNAL OF SURGICAL EDUCATION 2008; 65:140-144. [PMID: 18439539 DOI: 10.1016/j.jsurg.2007.10.001] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/29/2007] [Revised: 10/01/2007] [Accepted: 10/03/2007] [Indexed: 05/26/2023]
Abstract
BACKGROUND We sought to investigate the efficacy of endoscopically created, full-thickness plications on the competency of the anti-reflux barrier when placed at different positions on the stomach adjacent to the gastroesophageal junction. METHODS Explanted human cadaver stomachs and esophagi were used. An endoscopic plication system (Plicator, NDO Surgical, Mansfield, Massachusetts) was then fitted over a pediatric gastroscope and passed through the esophagus into the stomach. A full-thickness plication implant was then deployed at 1 of 3 positions (fundus, anterior, and between the anterior and the lesser curvature) on the explanted stomach within 1 cm of the gastroesophageal junction. Intragastric pressure was measured before and after plication at the time of visible reflux from the esophagus (reflux threshold) using a water-perfused manometer. RESULTS Five explanted stomachs were used. The mean reflux threshold before plication (baseline) was 1.7 mm Hg. A single plication at each position resulted universally in a significantly increased reflux threshold over the baseline value (p < 0.006). The greatest reflux threshold was observed when plication was performed on the anterior wall of the stomach, although this reflux pressure did not achieve statistical significance over the other 2 positions. A second plication performed adjacent to the initial plication at the fundus (n = 2) and anterior (n = 2) positions did increase reflux threshold; however, this increase also failed to achieve statistical significance. CONCLUSIONS These results suggest that an endoscopic, full-thickness plication system can inhibit gastroesophageal reflux effectively in an explanted stomach model. Although anterior plication resulted in the greatest intragastric pressure at reflux, it was not significantly different from intragastric pressure recorded at the other plication positions. A second plication adjacent to the first showed incremental effect, but larger studies are warranted to understand its clinical significance.
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Affiliation(s)
- James P Dolan
- Division of General Surgery, Department of Surgery, and The Digestive Health Center, Oregon Health and Science University, Portland, OR, USA.
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McGee MF, Marks JM, Jin J, Williams C, Chak A, Schomisch SJ, Andrews J, Okada S, Ponsky JL. Complete endoscopic closure of gastric defects using a full-thickness tissue plicating device. J Gastrointest Surg 2008; 12:38-45. [PMID: 17957435 DOI: 10.1007/s11605-007-0371-0] [Citation(s) in RCA: 39] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/22/2007] [Accepted: 09/20/2007] [Indexed: 01/31/2023]
Abstract
Obtaining endolumenal closure of hollow visceral defects may complement conventional, incision-based, surgical alternatives and benefit the experimental field of natural orifice translumenal endoscopic surgery (NOTES). Endoscopic tissue plicating devices (TPD) represent a promising closure technology; however, the long-term integrity of resultant closures is uncertain. Swine (n=10) underwent survival transgastric NOTES peritoneoscopy procedures with TPD gastrotomy closure while device performance and closure integrity were evaluated. Following uncomplicated procedures, no animals revealed leakage on upper gastrointestinal contrast fluoroscopy immediately following closure and on postoperative days 2 and 7. Necropsy performed on the 14th postoperative day revealed a subclinical colonic injury for one animal; the remaining nine animals had no complications. Gastric burst testing revealed the strength of closure was comparable to that of nonsurgical control stomachs (85.1 vs. 85.3 mm Hg, p=0.98). For six of nine (66%) TPD animals, bursting occurred remote to the closure site in nonsurgical tissue, indicating that closure strength equaled that of native tissue. Endoscopic TPD closure of standardized NOTES gastric defects results in strong, leak-proof closure; however, injuries can occur. These findings support evaluation of TPD closure in human trials involving noncontrolled gastric defects.
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Affiliation(s)
- Michael F McGee
- Department of Surgery, University Hospitals Case Medical Center, Case Western Reserve University, 11100 Euclid Avenue, 7th Floor Lakeside Bldg, Cleveland, OH 44106, USA
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Systematic review: endoluminal therapy for gastro-oesophageal reflux disease: evidence from clinical trials. Eur J Gastroenterol Hepatol 2007; 19:1125-39. [PMID: 17998840 DOI: 10.1097/meg.0b013e3282f16a21] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
During the last few decades many endoscopic interventions have been developed as an alternative for the treatment of gastro-oesophageal reflux disease (GORD). In many countries, these interventions are thus being performed in the general clinical setting. The aim of this study is to systematically review the evidence on the effect of endoscopic therapies for GORD. A systematic search of the literature on this subject in English, indexed in MEDLINE (1966 to May 2007) and in the Cochrane Library, was carried out. For the study selection, retrospective and prospective open-label and randomized, sham-controlled trials were taken into account. The exclusion criteria included the following: case series that included fewer than 10 patients, abstracts, studies involving children or those with a follow-up shorter than 3 months. For data extraction, two reviewers, using standardized forms, independently abstracted data on study design and methods, population, sample size, function studies (e.g. pH-metry), type of endoscopic treatment, follow-up, health-related and quality of life scores, outcomes and complications. Data synthesis involved the following: 43 studies, including four randomized, sham-controlled trials that met the inclusion criteria, out of 4182 citations. The primary end point in most studies was the reduction of the use of proton pump inhibitors (PPIs) by more than 50%. In view of these findings, the majority of studies suggested the efficacy of endoluminal therapies for the control of symptoms in GORD. In the sham-controlled studies, the effect of placebo was, nevertheless, as high as 50%. Most studies were small feasibility studies, with follow-ups of less than 1 year. No study comparing endoscopic techniques with other established treatment options such as PPIs existed. All endoscopic therapies were associated with a small but important percentage of mild to severe complications, which included perforation, abscess and death. In conclusion, the data from most of the short-term follow-up and the few sham-controlled studies demonstrate that subgroups of patients experienced improvement or resolution of typical GORD symptoms and decreased PPI usage. Currently, however, there are not enough scientific and clinical data on safety, efficacy and durability to support the use of endoluminal therapies for GORD in routine clinical practice.
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Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lo S, Hawes R, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: Five-year long-term multicenter results. Surg Endosc 2007; 22:326-32. [PMID: 18027032 DOI: 10.1007/s00464-007-9667-0] [Citation(s) in RCA: 37] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/30/2007] [Revised: 09/24/2007] [Accepted: 10/09/2007] [Indexed: 01/03/2023]
Abstract
BACKGROUND The Plicator (NDO Surgical, Inc., Mansfield, MA) endoscopically places a full-thickness permanent suture to augment the antireflux barrier. At 3-years post-treatment, published results demonstrated a reduction in subjects' gastroesophageal reflux disease (GERD) symptoms and related medication use. AIM To evaluate the Plicator's safety and durability of effect at improving GERD symptoms at 5-years post-treatment. METHODS A total of 33 chronic GERD sufferers across seven sites were followed for approximately 5 years (median follow-up: 59 months, range 50-65 months) after receiving a single full-thickness plication approximately 1 cm below the gastroesophageal (GE) junction in the anterior gastric cardia. At baseline, 30 out of 33 subjects required daily proton-pump inhibitor (PPI) therapy. RESULTS Of the subjects who were PPI dependent prior to treatment 67% (20/30) remained off daily PPI therapy at 60 months and 5-year median GERD health-related quality-of-life (HRQL) scores show significant improvement from baseline off-meds scores (10 versus 19, p < 0.001). Additionally, 50% (16/32) of subjects achieved >or= 50% score improvement in GERD-HRQL. No new adverse events were identified and all device-related events occurred acutely. These results were comparable to the results seen at 36 months follow-up. CONCLUSIONS Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 5-years post procedure with no long-term adverse events post treatment.
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Affiliation(s)
- Douglas Pleskow
- Beth Israel Deaconess Medical Center, 330 Brookline Avenue, DA-501, Boston, MA 02215, USA
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McGee MF, Marks JM, Onders RP, Chak A, Jin J, Williams CP, Schomisch SJ, Ponsky JL. Complete endoscopic closure of gastrotomy after natural orifice translumenal endoscopic surgery using the NDO Plicator. Surg Endosc 2007; 22:214-20. [PMID: 17786515 DOI: 10.1007/s00464-007-9565-5] [Citation(s) in RCA: 65] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/19/2007] [Accepted: 06/05/2007] [Indexed: 12/21/2022]
Abstract
BACKGROUND The NDO Plicator is a device developed for endoscopic treatment of gastroesophageal reflux disease (GERD) by approximation of tissues together with a double-pledgeted U-stitch. It was theorized that this device may facilitate transgastric natural orifice translumenal endoscopic surgery (NOTES) because closure of the transgastric defect remains a key component for advancement of this new technology. METHODS A standardized 12-mm gastrotomy was created endoscopically in four pigs using a combination of needle-knife cautery and balloon dilation. As the endoscope was removed, a Savary soft-tipped wire was introduced into the stomach, and the NDO Plicator was subsequently advanced over the wire. Each defect was identified, and the device was positioned. If necessary, the Plicator's tissue grasper was used to hold the superior aspect of the gastrotomy and bring the opposed borders of the defect within the jaws of the device. The device was fired three times, leaving three pledgeted suture bundles to close the gastric defect. After closure, each animal was explored, and the integrity of the closure was assessed. The animals underwent in vivo contrast fluoroscopy and ex vivo burst pressure testing studies for assessment of leakage at the closure site. RESULTS The first animal was used to test feasibility, refine techniques, and develop a standard procedure. All of the next three animals studied showed complete sealing of the gastrotomy site without evidence of contrast extravasation on multiplanar fluoroscopic imaging. Each stomach was excised, submerged in water, and subjected to a pressurized air leak test. No leaks were noted until pressures exceeded 55 mmHg. CONCLUSION This study supports the use of the NDO Plicator for closure of standardized gastric defects in a porcine model. In addition to closing NOTES gastrotomies, the NDO Plicator may be a particularly useful tool for obtaining complete closure of gastric perforations and anastomotic leaks, and for performing stomal reduction after gastric bypass procedures. The mechanical properties of a closure are not the only factor determining whether a leak will develop. Tissue opposition, ischemia, and tension are important factors that are not easily or reliably measured. The physiologic relevance of gastric bursting pressure is not known. Therefore, corollary animal studies with longer-term evaluation are necessary before research proceeds to clinical trials.
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Affiliation(s)
- M F McGee
- Department of Surgery, Case Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106, USA
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Abstract
Today, there are several modalities to treat gastroesophageal reflux disease (GERD) (medications, endoscopic therapies, surgery) and such therapies can be used either singly, or in tandem, or in combination with the others, aiming at "normalization" of the patient's GERD-related quality of life and, if possible, esophageal acid exposure. Several intermediate end points or clinically significant outcomes have not been reached by some therapeutic modalities and no single modality is or can be perfect. Statistically significant improvements in these intermediate end points have been shown in "some" but not all studies. Although healing of esophagitis can be accomplished with either medical or surgical therapy, there is inadequate data with endotherapies, because most patients treated with endotherapies have had prior trials of proton pump inhibitors (PPIs) and hence healed their esophagitis. Effective prevention of complications, such as esophageal adenocarcinoma, remains challenging for all modalities. Patients who have not normalized their GERD-related quality of life with once or twice daily PPI therapy should undergo functional esophageal evaluation with pH testing and esophageal motility study and they should be evaluated by both an endoscopist and a surgeon. The decision on how to proceed should be made on the basis of the criteria for endotherapy and surgery, availability of local endoscopic and surgical expertise and patients' preference. Such multimodality therapy model is in many ways similar to the long-term management of coronary artery disease where pharmacotherapy, angioplasty, and bypass surgery are frequently used in tandem or in combination. Multimodality therapy aiming at normalization of GERD-related quality of life is an option today, and should be available to all patients in need of therapy. The target population for GERD endotherapy currently consists of PPI-dependent GERD patients, who have a small (<2-cm-long) or no sliding hiatal hernia, and without severe esophagitis or Barrett esophagus. Thus far, only Stretta and the NDO plicator have been studied in sham-controlled trials. Registries of complications suggest that these techniques are relatively safe, but serious morbidity, including rare mortality have been reported (for a continuous update on complications related to endoscopic therapies see: http://www.fda.gov/cdrh/maude.html). All can be performed on an outpatient basis, under intravenous sedation and local pharyngeal anesthesia. Future comparative studies with predetermined clinically significant end points, validated outcome measures, prolonged follow-up, and complete complication registries will eventually determine the precise role of endoscopic procedures for the patients with GERD.
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Affiliation(s)
- George Triadafilopoulos
- Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA 94305-5187, USA.
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Abstract
A paradigm shift in therapeutic endoscopy occurred with the advent of mucosectomy for the treatment of mucosal neoplasms and suture plication for gastroesophageal reflux disease. The objectives changed from finding simple, easy, and quick alternatives to surgery to reproducing surgical results. A radical version of flexible endoscopy has emerged to meet new goals of full-thickness resections, creation of anastomoses, and lumen reconfiguration. This will require a new generation of endosurgical tools that cut, stitch, and staple with added dimensions of multiaxis orientation and triangulation.
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Affiliation(s)
- Kenneth F Binmoeller
- California Pacific Medical Center, Interventional Endoscopy Services, 2333 Buchannan Street, 5th Floor, San Francisco, CA 94115, USA.
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Abstract
In GERD patients in whom pharmacological therapies are ineffective and anti-reflux surgery is not indicated, a viable option could be proposed. To date, several endoscopic antireflux procedures, involving sewing, injection and/or implant, and radiofrequency are available. The sewing techniques demonstrated good clinical results, with reduction in proton pump inhibitors consumption; despite significant changes in esophageal manometry and/or acid exposure time reduction and healing of esophagitis were noted only in few patients.
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Affiliation(s)
- Michele Marchese
- Digestive Endoscopy Unit, Catholic University of Rome, Largo Francesco Vito 1, 00168 Rome, Italy
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Torquati A, Richards WO. Endoluminal GERD treatments: critical appraisal of current literature with evidence-based medicine instruments. Surg Endosc 2007; 21:697-706. [PMID: 17401603 DOI: 10.1007/s00464-007-9344-3] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2007] [Accepted: 02/13/2007] [Indexed: 12/12/2022]
Abstract
BACKGROUND The literature of endoluminal treatment of gastroesophageal reflux disease (GERD) widely varies in the level of evidence presented for analysis. Therefore there is a need for a comprehensive evidence-based medicine (EBM) analysis of the current literature evidence of the three FDA-approved modalities used for endoluminal treatment of GERD. SEARCH STRATEGY In January 2007, the MEDLINE database was searched for randomized controlled trials (RCTs), and controlled clinical trials of currently available endoluminal treatment of GERD. Database searches combined the specific endoluminal device keywords with the condition-specific keyword (e.g., GERD). DATA COLLECTION AND ANALYSIS All relevant studies have been categorized according to the evidence they provide according to the guidelines for Levels of Evidence and Grades of Recommendation supplied by the Oxford Centre for Evidence-Based Medicine. MAIN RESULTS AND AUTHORS' CONCLUSION: Sixteen studies met the inclusion criteria, representing 787 patients. The methodological quality of most of the included studies was average; four studies were grade 1b (individual randomized trial), 10 were grade 2b (individual cohort study), and two were grade 3b (individual case-control study) There is grade 1b and 2b evidence demonstrating the EndoCinch plication is effective in reducing GERD symptoms at short-term follow up. However, in the majority of the studies analyzed, the procedure does not significantly reduce the acid exposure in the distal esophagus. The majority of the studies with long-term outcome showed disappointing outcomes, probably due to suture loss in the majority of patients. There is grade 1b and 2b evidence demonstrating that the Stretta procedure is effective in reducing GERD symptoms at short- and mid-term follow up. However, in the majority of the studies analyzed, the procedure did not reduce significantly the acid exposure in the distal esophagus. There is grade 1b and 2b evidence demonstrating that full-thickness plication is effective in reducing GERD symptoms, and acid exposure in the distal esophagus.
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Affiliation(s)
- Alfonso Torquati
- Department of Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA
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Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results. Surg Endosc 2006; 21:439-44. [PMID: 17180259 DOI: 10.1007/s00464-006-9121-8] [Citation(s) in RCA: 49] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/11/2006] [Revised: 08/11/2006] [Accepted: 09/25/2006] [Indexed: 01/03/2023]
Abstract
BACKGROUND The purpose of the present study was to assess the long-term safety and durability of effect for endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux disease (GERD). The Plicator (NDO Surgical, Inc., Mansfield, MA) used delivers a transmural suture through the gastric cardia to restructure the antireflux barrier. Published reports have shown the Plicator procedure to be effective in reducing GERD symptoms and medication use at 1 year post-plication. METHODS Twenty-nine patients with chronic heartburn requiring maintenance daily anti-secretory therapy were treated at five sites. Patients received a single full-thickness plication in the gastric cardia 1cm below the gastroesophageal junction (GE) junction. Re-treatments were not permitted. Patients were evaluated at baseline for GERD symptoms and medication use. Intermediate (12 month) and long-term subject follow-up (median follow-up: 36.4 months; range, 31.2-43.9 months) were completed to evaluate procedure safety and durability of effect. RESULTS Twenty-nine patients completed the 12-month and 36-month follow-up. All procedure-related adverse events occurred acutely, and no new events were observed during extended follow-up. At 36-months post-procedure, 57% (16/28) of baseline proton pump inhibitor (PPI)-dependent patients remained off daily PPI therapy. Treatment effect remained stable from 12- to 36-months, with 21/29 patients off daily PPI at 12 months compared to 17/29 patients at 36-months. Median GERD- Health Related Quality of Life (HRQL) scores remained significantly improved at 36 months versus baseline off-meds scores (8 versus 19, p < 0.001). In addition, the proportion of patients achieving > or = 50% improvement in GERD-HRQL score was consistent from 12 months (59%) to 36 months (55%). CONCLUSIONS Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 3-years post-procedure. Treatment effect is stable from 1 to 3 years, and there are no long-term procedural adverse effects.
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Affiliation(s)
- D Pleskow
- Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, USA
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32
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Falk GW, Fennerty MB, Rothstein RI. AGA Institute technical review on the use of endoscopic therapy for gastroesophageal reflux disease. Gastroenterology 2006; 131:1315-36. [PMID: 17030199 DOI: 10.1053/j.gastro.2006.08.019] [Citation(s) in RCA: 47] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Affiliation(s)
- Gary W Falk
- Department of Gastroenterology and Hepatology, Center for Swallowing and Esophageal Disorders, Cleveland Clinic, Cleveland, OH, USA
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33
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Rothstein R, Filipi C, Caca K, Pruitt R, Mergener K, Torquati A, Haber G, Chen Y, Chang K, Wong D, Deviere J, Pleskow D, Lightdale C, Ades A, Kozarek R, Richards W, Lembo A. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial. Gastroenterology 2006; 131:704-12. [PMID: 16952539 DOI: 10.1053/j.gastro.2006.07.004] [Citation(s) in RCA: 103] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/01/2006] [Accepted: 06/08/2006] [Indexed: 01/11/2023]
Abstract
BACKGROUND & AIMS The aim of this study was to determine the effectiveness of endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease (GERD) in comparison with a sham procedure. METHODS Patients with symptomatic GERD requiring maintenance proton pump inhibitor (PPI) therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary end point was > or =50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included medication use and esophageal acid exposure. RESULTS By intention-to-treat analysis, at 3 months, the proportion of patients achieving > or =50% improvement in GERD-HRQL score was significantly greater in the active group (56%) compared with the sham group (18.5%; P < .001). Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis (50% vs 24%; P = .002). The percent reduction in median percent time pH < 4 was significantly improved within the active group versus baseline (7 vs 10, 18%, P < .001) but not in the sham group (10 vs 9, -3%, P = .686). Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH < 4 (P = .010). There were no perforations or deaths. CONCLUSIONS Endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure.
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Affiliation(s)
- Richard Rothstein
- Section of Gastroenterology and Hepatology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, USA.
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von Rahden BHA, Stein HJ. Endoscopic treatment modalities for gastroesophageal reflux disease (GERD). Eur Surg 2006. [DOI: 10.1007/s10353-006-0263-7] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
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Iqbal A, Salinas V, Filipi CJ. Endoscopic therapies of gastroesophageal reflux disease. World J Gastroenterol 2006; 12:2641-55. [PMID: 16718747 PMCID: PMC4130969 DOI: 10.3748/wjg.v12.i17.2641] [Citation(s) in RCA: 18] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/08/2005] [Revised: 08/13/2006] [Accepted: 08/30/2005] [Indexed: 02/06/2023] Open
Abstract
The high prevalence of gastroesophageal reflux disease (GERD) in Western societies has accelerated the need for new modalities of treatment. Currently, medical and surgical therapies are widely accepted among patients and physicians. New potent antisecretory drugs and the development of minimally invasive surgery for the management of GERD are at present the pivotal and largely accepted approaches to treatment. The minimally invasive treatment revolution, however, has stimulated several new endoscopic techniques for GERD. Up to now, the data is limited and further studies are necessary to compare the advantages and disadvantages of the various endoscopic techniques to medical and laparoscopic management of GERD. New journal articles and abstracts are continuously being published. The Food and Drug Administration has approved 3 modalities, thus gastroenterologists and surgeons are beginning to apply these techniques. Further trials and device refinements will assist clinicians. This article will present an overview of the various techniques that are currently on study. This review will report the efficacy and durability of various endoscopic therapies for gastroesophageal reflux disease (GERD). The potential for widespread use of these techniques will also be discussed. Articles and abstracts published in English on this topic were retrieved from Pubmed. Due to limited number of studies and remarkable differences between various trials, strict criteria were not used for the pooled data presented, however, an effort was made to avoid bias by including only studies that used off-PPI scoring as baseline and intent to treat.
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Affiliation(s)
- Atif Iqbal
- Department of Surgery, University of Missouri Columbia, One Hospital Drive, 65211, USA
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36
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Pasricha PJ, Pham BV. Endoscopic therapy for GERD: is the evidence for efficacy any stronger? ACTA ACUST UNITED AC 2006; 9:59-68. [PMID: 16423314 DOI: 10.1007/s11938-006-0024-5] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
Gastroesophageal reflux disease (GERD) is a common chronic medical disorder that has a significant impact on quality of life and afflicts millions of people worldwide. Therapy with either daily medications or surgical fundoplication, though highly effective for the majority of patients, is not without long-term shortcomings. The development of endoscopic antireflux therapies has been fueled by the hope of providing safe, effective, long-term symptomatic relief. Although several studies have been published, they are limited by small sample size, lack of adequate controls, and a highly selective patient population. However, it is clear that many, if not most, patients will continue to be on acid-suppressive therapy despite these procedures. Also, reports of postmarketing adverse effects emphasize the need for further scrutiny of the safety of these devices. This review will summarize the available evidence and provide tentative conclusions about the current and evolving role of endoscopic antireflux therapy.
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Affiliation(s)
- Pankaj J Pasricha
- University of Texas Medical Branch, 4.106 McCullough Building, 301 University Boulevard, Galveston, TX 77555-0764, USA.
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Domagk D, Menzel J, Seidel M, Ullerich H, Pohle T, Heinecke A, Domschke W, Kucharzik T. Endoluminal gastroplasty (EndoCinch) versus endoscopic polymer implantation (Enteryx) for treatment of gastroesophageal reflux disease: 6-month results of a prospective, randomized trial. Am J Gastroenterol 2006; 101:422-30. [PMID: 16542275 DOI: 10.1111/j.1572-0241.2006.00533.x] [Citation(s) in RCA: 18] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES The aim of this study was to compare and determine the efficiency and safety of two newly introduced endoscopic antireflux procedures in the treatment of gastroesophageal reflux disease (GERD). METHODS In a prospective, randomized trial, endoluminal gastroplasty (EndoCinch) was compared with polymer injection (Enteryx) employing 51 consecutive patients dependent on proton pump inhibitor therapy. Follow-up evaluation included drug consumption, symptoms, quality-of-life scoring, endoscopy, pH monitoring, manometry, and documentation of adverse events. RESULTS Twenty-six patients were assigned to EndoCinch treatment, 23 patients received Enteryx implantation, and two patients dropped out before applying endoscopic therapy. At 6 months, proton pump inhibitor therapy could be stopped or dosage was reduced by > or =50% in 20 of 26 (77%) EndoCinch-treated patients and in 20 of 23 patients treated by Enteryx (87%, p= 0.365), which differed significantly in both groups compared to the pre-interventional status (p < 0.0001). Esophageal acid reflux (pH < 4) decreased from 14.5% to 9.6% in EndoCinch-treated patients (p= 0.071) and from 15.5% to 13.9% in patients treated by Enteryx (p= 0.930). Heartburn symptom score, modified DeMeester score, gastrointestinal life quality index, and SF-36 physical health survey score improved significantly in both groups postinterventionally (p < 0.0001). Approximately 25% of the patients in both groups required retreatment in an attempt to achieve symptom control. CONCLUSIONS This is the first prospective, randomized study directly comparing two endoscopic anti-GERD techniques. EndoCinch and Enteryx seem to be equally successful in the treatment of GERD significantly reducing the proton pump inhibitor dosages, and also by improving symptoms of patients. Both endoluminal antireflux procedures may be promising therapeutic options; long-term evaluation will have to show if the positive initial results can be maintained.
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Affiliation(s)
- Dirk Domagk
- Department of Medicine B, University of Muenster, Albert-Schweitzer-Strasse 33, D-48129 Muenster, Germany
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Fass R, Shapiro M, Dekel R, Sewell J. Systematic review: proton-pump inhibitor failure in gastro-oesophageal reflux disease--where next? Aliment Pharmacol Ther 2005; 22:79-94. [PMID: 16225480 DOI: 10.1111/j.1365-2036.2005.02531.x] [Citation(s) in RCA: 287] [Impact Index Per Article: 14.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
Proton-pump inhibitor failure has become a common clinical dilemma in gastrointestinal clinics and has been increasingly encountered at the primary care level as well. Underlying mechanisms are diverse and may overlap. Most patients who have proton-pump inhibitor failure are likely to originate from the non-erosive reflux disease phenotype. Currently, available diagnostic modalities provide limited clues to the exact underlying cause. Treatment relies primarily on escalating dosing of proton-pump inhibitors. However, new insights into the pathophysiology of proton-pump inhibitor failure are likely to provide alternative therapeutic options.
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Affiliation(s)
- R Fass
- The Neuro-Enteric Clinical Research Group, Section of Gastroenterology, Southern Arizona VA Health Care System and University of Arizona, School of Medicine, Tucson, AZ, USA.
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Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial. Gastrointest Endosc 2005; 61:643-9. [PMID: 15855966 DOI: 10.1016/s0016-5107(04)02648-3] [Citation(s) in RCA: 60] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
BACKGROUND The aim of this study was to assess the intermediate-term (12-month) safety and efficacy of endoscopic full-thickness plication in patients with symptomatic GERD. METHODS Sixty-four patients with chronic heartburn that required maintenance antisecretory therapy received a single, endoscopically placed, full-thickness plication in the gastric cardia 1 cm distal to the gastroesophageal junction. At baseline and 12 months after plication, patients completed the GERD Health Related Quality of Life questionnaire, Gastrointestinal Symptom Rating Scale, and SF-36 Health Survey, as well as a medication use diary. Ambulatory 24-hour pH monitoring and esophageal manometry were obtained at baseline and 3 months after plication. At 6 months after plication, the 24-hour pH study was repeated. RESULTS Of the 57 patients who completed the 12-month follow-up, 40 (70%) were no longer taking a proton pump inhibitor. Median GERD Health Related Quality of Life scores were improved compared with baseline while taking medication (19.0 vs. 5.0; p < 0.0001) and while not taking medication (13.0 vs. 5.0; p < 0.002). At 6 months after the procedure, an improvement in distal esophageal acid exposure was demonstrated in 40 of 51 patients (80%), with a decrease of 39% in the median percentage of time the pH was less than 4 (p < 0.0001). Normal pH scores were observed in 30% of patients. All procedure-related adverse events occurred acutely, as previously reported, and no new adverse event was observed during extended follow-up. CONCLUSIONS Full-thickness plication at the gastroesophageal junction is an effective endoscopic procedure for treatment of patients with symptoms caused by GERD. It reduces reflux symptoms and antisecretory medication use over at least a 1-year period.
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Affiliation(s)
- Douglas Pleskow
- Division of Gastroenterology, Department of Medicne, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA
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Johnson DA. Evaluation of esophageal function/pH in endoscopic therapy for gastroesophageal reflux disease. Gastrointest Endosc Clin N Am 2005; 15:333-45. [PMID: 15722245 DOI: 10.1016/j.giec.2004.10.012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
Gastroesophageal reflux disease (GERD) typically requires lifelong medical therapy or surgery for the management of patients with frequent symptoms. The current standard of care is to prescribe medical therapy using proton pump inhibitors. Patients with moderate-to-severe GERD require extended/maintenance therapy. Until recently, the only alternative to this approach was surgical intervention. Endoscopic therapy for GERD has emerged as a second alternative strategy. Primary endpoints for all interventions have aimed at symptomatic control and reduction/discontinuance of medication use. For surgical and endoscopic therapies, however, there are other physiologic endpoints that have attempted to define changes in lower esophageal sphincter pressure and esophageal acid exposure. For patients being evaluated for endoscopic GERD therapy, the author recommends comprehensive esophageal testing and pH testing.
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Affiliation(s)
- David A Johnson
- Department of Gastroenterology, Eastern Virginia School of Medicine, 700 W. Olney Road, Norfolk, VA 23501, USA.
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Cappell MS. Clinical presentation, diagnosis, and management of gastroesophageal reflux disease. Med Clin North Am 2005; 89:243-91. [PMID: 15656927 DOI: 10.1016/j.mcna.2004.08.015] [Citation(s) in RCA: 17] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
GERD is ubiquitous throughout the adult population in the United States. It commonly adversely affects quality of life and occasionally causes life-threatening complications. The new and emerging medical and endoscopic therapies for GERD and the new management strategies for BE should dramatically reduce the clinical toll of this disease on society.
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Affiliation(s)
- Mitchell S Cappell
- Division of Gastroenterology, Department of Medicine, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA 19141-3098, USA.
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44
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Abstract
In the West, gastroesophageal reflux disease (GERD) is a common and well-recognized disease. Lately, it has been described as an emerging problem in the East as well. While it is not a rapidly fatal illness, it causes a myriad of disturbing symptoms that remarkably reduce the patients' quality of life (QOL). The economic impact that results from multiple consultations, diagnostic investigations, and administration of a variety of treatment regimens, including surgery, is enormous. The operative management for GERD is fundoplication, for example Toupet (270 degree wrap of the distal esophagus) and Nissen (360 degree wrap of the distal esophagus). These surgical procedures are aimed at permanently controlling acid reflux by reconstructing the gastroesophageal junction. Currently, the ease, aesthetic advantages, and the comparable outcomes achieved by minimally invasive laparoscopic fundoplication have rekindled interest in the operative alternatives of GERD management. Fundoplication controls or diminishes considerably the severity of the symptoms associated with GERD. However, appearance of new symptoms i.e. dysphagia, 'gas-bloat syndrome', etc. as postoperative events have been reported. Recently, several innovative endoluminal treatment modalities have been introduced, namely; endoscopic plicator/suturing devices, bulking injections, and radiofrequency treatment. They are focused on enhancing the performance of a malfunctioning lower esophageal sphincter. While results of several case series reflect substantial improvements in GERD-HRQL scores, lack of long-term durability data is a major concern when recommending these novel, relatively simple, peroral techniques to a long suffering patient. It is clear that these therapies are still evolving and long-term outcomes of properly designed comparative efficacy trials are awaited.
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Affiliation(s)
- Jose D Sollano
- Section of Gastroenterology, University of Santo Tomas, Manila, Philippines.
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45
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Abstract
PURPOSE OF REVIEW Gastroesophageal reflux disease (GERD) is a very common disorder that affects substantially the patient's quality of life. A number of important new developments in the diagnosis, clinical management, and medical, endoscopic, and surgical therapies were described in 2003, and they are summarized here. RECENT FINDINGS Most patients with symptomatic GERD do not have erosive reflux disease. Transient lower esophageal sphincter relaxations and hiatal hernias have emerged as major and interacting factors in GERD. Stretch receptors in the fundus are more relevant than tension receptors in triggering transient lower esophageal sphincter relaxations and subsequent reflux. The wireless Medtronic Bravo pH system has been validated as an alternative to conventional pH monitoring and has better tolerability. The mainstay of medical therapy for GERD is the use of proton pump inhibitors, with as yet no superiority of any one agent over all others. Several endoscopic antireflux therapies aiming at creating an antireflux barrier and reducing or eliminating the need for chronic medical therapy or fundoplication have been introduced and validated as feasible, safe, and effective. It may be possible now to stratify patients with GERD to treatment with either endoscopic therapy or surgery according to the size of hiatal hernia, lower esophageal sphincter pressure, Barrett esophagus, and significant pulmonary symptoms. SUMMARY Key developments in the recognition and management of GERD in 2003 will have significant implications for clinical practice or research.
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Affiliation(s)
- G Triadafilopoulos
- Stanford University School of Medicine, Stanford, California 94305, USA.
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