Endoscopic Resection in Gastro-Esophageal Reflux Disease (RESECT-RGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03357809
Recruitment Status : Suspended (lake of efficiency and poor tolerance of endoscopic technique)
First Posted : November 30, 2017
Last Update Posted : September 3, 2018
Information provided by (Responsible Party):
Arthur Laquiere, 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.

Condition or disease Intervention/treatment Phase
GERD Gastro Esophageal Reflux Procedure: Endoscopic mucosal resection Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal Reflux Disease
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : April 10, 2019
Estimated Study Completion Date : April 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Arm Intervention/treatment
Experimental: Endoscopic treatment
Procedure: Endoscopic 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.

Primary Outcome Measures :
  1. Rate of patients no longer requiring medical treatment at 6 months [ Time Frame: 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 :
  1. Improvement in quality of life [ Time Frame: 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.

  2. Improvement of gastric PH [ Time Frame: 6 months ]
    Improvement of gastric PH metric dosages.

  3. Evaluation for morbidity [ Time Frame: 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03357809

Marseille, France, 13008
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
Principal Investigator: Arthur Laquière, MD French Society of Digestive Endoscopy

Publications of Results:

Responsible Party: Arthur Laquiere, Principal investigator, Hospital St. Joseph, Marseille, France Identifier: NCT03357809     History of Changes
Other Study ID Numbers: 2016-A01591-50
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases