Clinical trial NCT03357809: Endoscopic Resection in Gastro-Esophageal Reflux Disease
Official title: Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: GERD
Gastro Esophageal Reflux
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients no longer requiring medical treatment at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Improvement in quality of life
timeFrame: 6 months
measure: Improvement of gastric PH
timeFrame: 6 months
measure: Evaluation for morbidity
timeFrame: 30 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: LAQUIERE
Study officials:
affiliation: French Society of Digestive Endoscopy
name: Arthur Laquière, MD
role: PRINCIPAL_INVESTIGATOR
References:
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