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

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ClinicalTrials.gov Identifier: NCT03357809
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
GERD Gastro Esophageal Reflux Procedure: Endoscopic mucosal resection

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Endoscopic treatment
ENDOSCOPIC MUCOSAL RESECTION AT DAY 1
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.



Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT03357809


Contacts
Contact: Arthur Laquière, MD 0491808207 ext 33 alaquiere@gmail.com
Contact: Laurence Lecomte 0491808207 ext 33 llecomte@hopital-saint-joseph.fr

Locations
France
LAQUIERE Recruiting
Marseille, France, 13008
Contact: Arthur Laquière, MD    0491808207 ext 33    alaquiere@gmail.com   
Contact: Laurence Lecomte    0491808207 ext 33    llecomte@hopital-saint-joseph.fr   
Principal Investigator: Arthur Laquière, MD         
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
Investigators
Principal Investigator: Arthur Laquière, MD French Society of Digestive Endoscopy
More Information

Publications:

Responsible Party: Arthur Laquiere, Principal investigator, Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT03357809     History of Changes
Other Study ID Numbers: 2016-A01591-50
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
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