Gastro Esophageal Reflux, GERD
Conditions
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
Interventions
PROCEDUREEndoscopic mucosal resection
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.
Sponsors
Hospital St. Joseph, Marseille, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed