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

NCT ID: NCT05745012

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-12-31

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.

Conditions

Gastroesophageal Reflux Disease With Ulceration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

group A: control group

Group Type: SHAM_COMPARATOR

sham

Intervention Type: PROCEDURE

The procedure consists of performing endoscopic exploration, no mucosal resection

group B: ARMS procedure

Group Type: EXPERIMENTAL

endoscopic mucosal resection

Intervention Type: PROCEDURE

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.

Interventions

endoscopic mucosal resection

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

sham

The procedure consists of performing endoscopic exploration, no mucosal resection

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AP-HM

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-Michel Gonzalez, MD

Role: CONTACT

jean-michel.gonzalez@ap-hm.fr

0491368737 ext. +33

Amandine Rolland-Brun

Role: CONTACT

amandine.rolland@ap-hm.fr

0491381245 ext. +33

Facility Contacts

Jean-Michel Gonzalez, PR

Role: primary

jean-michel.gonzalez@ap-hm.fr

Other Identifiers

2022-A00599-34

Identifier Type: -

Identifier Source: org_study_id