GERD Clinical Trial
Official title:
Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal Reflux Disease
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.
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
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