NCT05745012

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

Anti-Reflux Mucosectomy (ARMS) in the Treatment of Refractory Gastro-esophageal Reflux (GERD): a Prospective Randomized Comparative Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	sham	The procedure consists of performing endoscopic exploration, no mucosal resection

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2023-02-27
• Last updated: 2023-02-27

Locations

1 site across 1 country: France