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

NCT05745012 | Unknown

• 1 other identifier: 2022-A00599-34
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  one year

Secondary Outcomes (13)

• Assessing the clinical efficacy at 6 months

  6 months

• Evaluating the impact on PPIs use after ARMS and sham procedures, respectively;

  one year

• Assessing the changes in abnormal exposure to esophageal acid induced by the procedure

  3 months

• Assessing the changes in abnormal exposure to esophageal acid induced by the procedure

  3 months

• Evaluating the impact of this technique on patients' quality of life;

  2 months

Study Arms (2)

group A: control group

SHAM COMPARATOR

Procedure: sham

group B: ARMS procedure

EXPERIMENTAL

Procedure: endoscopic mucosal resection

Interventions

endoscopic mucosal resection 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.

group B: ARMS procedure

sham PROCEDURE

The procedure consists of performing endoscopic exploration, no mucosal resection

group A: control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

AP-HM

Marseille, 13015, France

RECRUITING

MeSH Terms

Interventions

Endoscopic Mucosal Resection; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Jean-Michel Gonzalez, MD

CONTACT

0491368737; jean-michel.gonzalez@ap-hm.fr

Amandine Rolland-Brun

CONTACT

0491381245; amandine.rolland@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: operating gastroenterologist will be unblind while evaluating gastroenterologist will be blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: February 27, 2023
• Study Start: February 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)