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Anti-Reflux Mucosectomy in the Treatment of Refractory Gastro-esophageal Reflux (MARRGO)

Primary Purpose

Gastroesophageal Reflux Disease With Ulceration

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
endoscopic mucosal resection
sham
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease With Ulceration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient over 18 years old Patient that have read the information form and signed consent Patient covered with health insurance GERD with typical symptom of pyrosis, or atypical symptoms with clinical symptomatic correlation confirmed by pre-operative Ph-Impedencemetry performed in the last 6 months GERD evolving for at least 1 year, and refractory to medical treatment, which is defined by the persistence of daily GERD related symptoms despite PPI at 20mg twice daily associated with local topics and hygiene-dietary measures High-resolution manometry (HRM) to eliminate severe motor disorder and research lower esophageal sphincter hypotony performed in the last 6 months Eso-gastro-duodenoscopy (EGD) to confirm the absence of severe esophagitis, hiatal hernia, and complicated Barret's esophagus performed in the last 3 months Exclusion Criteria: Grade C peptic esophagitis (Los Angeles classification), persisting despite medical treatment at pre-inclusion gastroscopy (< 6 months) Hiatal hernia > 2cm at preoperative gastroscopy Barret's Esophagus > C0-M2 with relief abnormalities or confirmed high-grade dysplasia (2 endoscopies within 6 months) History of esophageal or gastric surgery Severe esophageal motility disorder at HRM such as achalasia or spastic disorder (Chicago classification); minor motility disorders may be included No french language comprehension Patient under tutelle or curatelle Patient already enrolled in interventional research

Sites / Locations

  • AP-HMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

group A: control group

group B: ARMS procedure

Arm Description

Outcomes

Primary Outcome Measures

demonstrate superiority of ARMS
the clinical efficacy defined as the decreasing of self-reported related-symptom GERD assessed using the GERD-HRQL score of more than 50% at one year

Secondary Outcome Measures

Assessing the clinical efficacy at 6 months
The clinical efficacy, as defined above, at 6 months
Evaluating the impact on PPIs use after ARMS and sham procedures, respectively;
The rate (and the date) of complete disruption of PPIs at 1 year if so, or, in case of decreasing the mean daily or weekly dose compared to before the intervention
Assessing the changes in abnormal exposure to esophageal acid induced by the procedure
The % time with Ph under 4 on post-operative (3 months) Ph-impedencemetry, compared to pre-operative
Assessing the changes in abnormal exposure to esophageal acid induced by the procedure
the De Meester score. The interpretation of the score is as follows: DMS <14.72 No GERD DMS 14.72 - 50 Mild GERD DMS 51 - 100 Moderate GERD DMS >100 Severe GERD
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 2 months These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 4 months These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 6 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 1 year. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on SF12 scores at 2 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on SF12 scores at 4 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on SF12 scores at 6 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Evaluating the impact of this technique on patients' quality of life;
The quality of life based on SF12 scores at 1 year. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Documenting the adverse events of the technique;
The adverse events rate of ARMS procedure, evaluated per-operatively and until 30 post-operative days, their severity assessed using the AGREE classification, and their management

Full Information

First Posted
September 5, 2022
Last Updated
February 15, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT05745012
Brief Title
Anti-Reflux Mucosectomy in the Treatment of Refractory Gastro-esophageal Reflux
Acronym
MARRGO
Official Title
Anti-Reflux Mucosectomy (ARMS) in the Treatment of Refractory Gastro-esophageal Reflux (GERD): a Prospective Randomized Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Gastroesophageal reflux disease (GERD) is one of the most common digestive diseases in Western countries, affecting 8% of the population in its typical and frequent form. For typical GERD without alarming symptoms, treatment combines PPI therapy and lifestyle modifications. Patients with an incomplete response to optimized PPI therapy have so-called refractory GERD. Anti-reflux mucosectomy (ARMS) is a recent technique that achieves endoscopic fundoplication by scar-induced tissue retraction using a mucosal ligation system combined with resection, known as the banded ligation system (ARM-b) [6]. Several studies have shown efficacy of approximately 65-70% on symptom resolution and quality of life improvement, including our pilot study of 21 patients, and without serious adverse events. The purpose of this study is therefore to prospectively evaluate in a randomized blinded comparison to a sham procedure and conventional medical follow-up, the efficacy of anti-reflux mucosectomy (ARMS) in the treatment of refractory GERD. The hypothesis is that we can achieve a clinical efficacy rate of 65% in the treatment group versus 35% in the control group. The primary objective is to demonstrate the superiority in terms of clinical efficacy (self-reported symptom-related GERD rate, GERD-SLR) of RAS compared to the sham procedure combined with optimized medical treatment at 1 year. The primary endpoint will be clinical efficacy, defined as a greater than 50% decrease in the number of GERD-associated symptoms, assessed using the GERD-HRQL score. Secondary objectives will be: Assessing clinical efficacy at 6 months. Assess the impact on PPI use Assess changes in procedure-induced abnormal esophageal acid exposure by Ph-metry Assess the impact of this technique on patient quality of life; To document the adverse effects of the technique (AGREE, Clavien Dindo and ASGE score) The duration of follow-up will be 1 year, and based on our hypothesis the number of patients to be included will be 130.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease With Ulceration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
operating gastroenterologist will be unblind while evaluating gastroenterologist will be blind
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A: control group
Arm Type
Sham Comparator
Arm Title
group B: ARMS procedure
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
endoscopic mucosal resection
Intervention Description
The procedure consists of performing endoscopic mucosal resection of the 3/4 of the circumference of the esogastric junction using the Duette system (Cook Endoscopy, USA). The procedure will be performed under general anesthesia in an intubated patient, and realized in ambulatory setting.
Intervention Type
Procedure
Intervention Name(s)
sham
Intervention Description
The procedure consists of performing endoscopic exploration, no mucosal resection
Primary Outcome Measure Information:
Title
demonstrate superiority of ARMS
Description
the clinical efficacy defined as the decreasing of self-reported related-symptom GERD assessed using the GERD-HRQL score of more than 50% at one year
Time Frame
one year
Secondary Outcome Measure Information:
Title
Assessing the clinical efficacy at 6 months
Description
The clinical efficacy, as defined above, at 6 months
Time Frame
6 months
Title
Evaluating the impact on PPIs use after ARMS and sham procedures, respectively;
Description
The rate (and the date) of complete disruption of PPIs at 1 year if so, or, in case of decreasing the mean daily or weekly dose compared to before the intervention
Time Frame
one year
Title
Assessing the changes in abnormal exposure to esophageal acid induced by the procedure
Description
The % time with Ph under 4 on post-operative (3 months) Ph-impedencemetry, compared to pre-operative
Time Frame
3 months
Title
Assessing the changes in abnormal exposure to esophageal acid induced by the procedure
Description
the De Meester score. The interpretation of the score is as follows: DMS <14.72 No GERD DMS 14.72 - 50 Mild GERD DMS 51 - 100 Moderate GERD DMS >100 Severe GERD
Time Frame
3 months
Title
Evaluating the impact of this technique on patients' quality of life;
Description
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 2 months These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Time Frame
2 months
Title
Evaluating the impact of this technique on patients' quality of life;
Description
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 4 months These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Time Frame
4 months
Title
Evaluating the impact of this technique on patients' quality of life;
Description
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 6 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Time Frame
6 months
Title
Evaluating the impact of this technique on patients' quality of life;
Description
The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 1 year. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Time Frame
one year
Title
Evaluating the impact of this technique on patients' quality of life;
Description
The quality of life based on SF12 scores at 2 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Time Frame
2 months
Title
Evaluating the impact of this technique on patients' quality of life;
Description
The quality of life based on SF12 scores at 4 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Time Frame
4 months
Title
Evaluating the impact of this technique on patients' quality of life;
Description
The quality of life based on SF12 scores at 6 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Time Frame
6 months
Title
Evaluating the impact of this technique on patients' quality of life;
Description
The quality of life based on SF12 scores at 1 year. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale
Time Frame
one year
Title
Documenting the adverse events of the technique;
Description
The adverse events rate of ARMS procedure, evaluated per-operatively and until 30 post-operative days, their severity assessed using the AGREE classification, and their management
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient over 18 years old Patient that have read the information form and signed consent Patient covered with health insurance GERD with typical symptom of pyrosis, or atypical symptoms with clinical symptomatic correlation confirmed by pre-operative Ph-Impedencemetry performed in the last 6 months GERD evolving for at least 1 year, and refractory to medical treatment, which is defined by the persistence of daily GERD related symptoms despite PPI at 20mg twice daily associated with local topics and hygiene-dietary measures High-resolution manometry (HRM) to eliminate severe motor disorder and research lower esophageal sphincter hypotony performed in the last 6 months Eso-gastro-duodenoscopy (EGD) to confirm the absence of severe esophagitis, hiatal hernia, and complicated Barret's esophagus performed in the last 3 months Exclusion Criteria: Grade C peptic esophagitis (Los Angeles classification), persisting despite medical treatment at pre-inclusion gastroscopy (< 6 months) Hiatal hernia > 2cm at preoperative gastroscopy Barret's Esophagus > C0-M2 with relief abnormalities or confirmed high-grade dysplasia (2 endoscopies within 6 months) History of esophageal or gastric surgery Severe esophageal motility disorder at HRM such as achalasia or spastic disorder (Chicago classification); minor motility disorders may be included No french language comprehension Patient under tutelle or curatelle Patient already enrolled in interventional research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Michel Gonzalez, MD
Phone
0491368737
Ext
+33
Email
jean-michel.gonzalez@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Amandine Rolland-Brun
Phone
0491381245
Ext
+33
Email
amandine.rolland@ap-hm.fr
Facility Information:
Facility Name
AP-HM
City
Marseille
ZIP/Postal Code
13015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel Gonzalez, PR
Email
jean-michel.gonzalez@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Anti-Reflux Mucosectomy in the Treatment of Refractory Gastro-esophageal Reflux

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