Endoscopic Resection in Gastro-Esophageal Reflux Disease

Study Overview
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Brief Summary
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Currently patients with gastroesophageal reflux disease (GERD) are treated with proton pump inhibitors (PPIs). This long-term PPI treatment would likely increase the risk of pulmonary and digestive infections and would not prevent evolution to adenocarcinoma of Barrett's Esophagus. Surgical fundoplication is generally recommended when symptoms are poorly controlled with PPIs and considered as standard treatment despite celioscopy risk. A variety of endoscopic techniques for the treatment of GERD has been proposed to obtain non-surgical control. These endoscopic techniques aim to bring the tissues closer to the Œsogastric (JOG) junction. But a low response rate has been demonstrated with these techniques. H. Inoue (inventor of the anti-reflux mucosectomy 20 years ago) and his team postulated that the reflux symptoms would be reduced by creating a relative restriction of gastric cardia. The healing of the mucosectomy zone led to restriction of gastric cardia. This observation suggested that ARMS could represent an effective anti-reflux procedure with the advantage that no prostheses would be left in situ. Few studies have evaluated this new endoscopic technique. The purpose of this study is to evaluate the feasibility and safety of gastric mucosectomy for patients with GERD resistant to medical treatment or requiring long-term maintenance medical treatment.

Detailed Description
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This is a monocentric prospective therapeutic study. Patients will be recruited in hepato-gastroenterology department of Saint Joseph Hospital (Marseille). A first clinical, endoscopic and PH impedance evaluation will be made. Mucosectomy will be scheduled depending on the results of the review. The patients will be followed for 2 years with esophageal and gastric PH-impedance monitoring at 6 months and 24 months. Health related quality of life questionnaires will be completed before ARMS, 6 and 24 months after mucosectomy. The characteristics of the patients will be compared to evaluate the % of responders and non-responders

Official Title
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Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal Reflux Disease

Conditions
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GERD, Gastro Esophageal Reflux

Intervention / Treatment
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* Procedure: Endoscopic mucosal resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with GERD resistant to medical treatment, or requiring daily long-term medical treatment Exclusion Criteria: Contraindications to the realization of a upper GI endoscopy Achalasia or other esophageal motor disorders Voluminous hiatal hernia Haemorrhagic, haemostasis or coagulation disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic treatment<br>ENDOSCOPIC MUCOSAL RESECTION AT DAY 1 | Procedure: Endoscopic mucosal resection<br>* Mucosectomy performed at day 1. Endoscopic mucosal resection (EMR) and or endoscopic submucosal dissection (ESD), is at least 3 cm long. The mucosal resection is carried out along the side of the small curvature of the stomach, in order to preserve a valve of the cardia at the level of the large curvature of the stomach. A coloured solution is injected into the submucosa following markers. The correct submucosal injection is confirmed by the lifting of the mucosal surface. A submucosal dissection is carried out using the dual knife. The mucosectomy is repeatedly performed until the mucosal zone is completely resected. The choice of the resection technique will depend on the anatomy of the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients no longer requiring medical treatment at 6 months | Suggest that endoscopic treatment would allow the cessation of medical treatment in 50% of cases Rate of patients no longer requiring medical treatment at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of life | Percentage of improvement in quality of life measured by the score obtained in the GERD-HRQL questionnaire evaluating the impact of GERD on quality of life. | 6 months | 
| Improvement of gastric PH | Improvement of gastric PH metric dosages. | 6 months | 
| Evaluation for morbidity | Rate of all observed complications in per and post immediate procedure (up to 30 minutes). The delayed morbidity of the procedure for the study will be defined by the rate of complications occurring after the examination and up to 30 days. Specially, the following events will be studied: digestive hemorrhage and digestive perforation | 30 days |