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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):
Arthur Laquiere, Hospital St. Joseph, Marseille, France

October 13, 2017
November 30, 2017
November 30, 2017
April 10, 2017
April 10, 2019   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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.
  • Improvement of gastric PH [ Time Frame: 6 months ]
    Improvement of gastric PH metric dosages.
  • 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
Same as current
Not Provided
Not Provided
 
Endoscopic Resection in Gastro-Esophageal Reflux Disease
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

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • GERD
  • Gastro Esophageal Reflux
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.

Experimental: Endoscopic treatment
ENDOSCOPIC MUCOSAL RESECTION AT DAY 1
Intervention: Procedure: Endoscopic mucosal resection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Same as current
April 10, 2023
April 10, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Arthur Laquière, MD 0491808207 ext 33 alaquiere@gmail.com
Contact: Laurence Lecomte 0491808207 ext 33 llecomte@hopital-saint-joseph.fr
France
 
 
NCT03357809
2016-A01591-50
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Arthur Laquiere, Hospital St. Joseph, Marseille, France
Hospital St. Joseph, Marseille, France
Not Provided
Principal Investigator: Arthur Laquière, MD French Society of Digestive Endoscopy
Hospital St. Joseph, Marseille, France
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP