Endoscopic Resection in Gastro-Esophageal Reflux Disease
- Conditions
- GERDGastro Esophageal Reflux
- Interventions
- Procedure: Endoscopic mucosal resection
- Registration Number
- NCT03357809
- Lead Sponsor
- Hospital St. Joseph, Marseille, France
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 15
- Patient with GERD resistant to medical treatment, or requiring daily long-term medical treatment
- Contraindications to the realization of a upper GI endoscopy
- Achalasia or other esophageal motor disorders
- Voluminous hiatal hernia Haemorrhagic, haemostasis or coagulation disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endoscopic treatment Endoscopic mucosal resection ENDOSCOPIC MUCOSAL RESECTION AT DAY 1
- Primary Outcome Measures
Name Time Method Rate of patients no longer requiring medical treatment at 6 months 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
- Secondary Outcome Measures
Name Time Method Improvement in quality of life 6 months 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.
Improvement of gastric PH 6 months Improvement of gastric PH metric dosages.
Evaluation for morbidity 30 days 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
Trial Locations
- Locations (1)
LAQUIERE
🇫🇷Marseille, France