Clinical trial NCT05745012: Anti-Reflux Mucosectomy in the Treatment of Refractory Gastro-esophageal Reflux
Official title: Anti-Reflux Mucosectomy (ARMS) in the Treatment of Refractory Gastro-esophageal Reflux (GERD): a Prospective Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux Disease With Ulceration
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: demonstrate superiority of ARMS
timeFrame: one year
Secondary outcomes:
measure: Assessing the clinical efficacy at 6 months
timeFrame: 6 months
measure: Evaluating the impact on PPIs use after ARMS and sham procedures, respectively;
timeFrame: one year
measure: Assessing the changes in abnormal exposure to esophageal acid induced by the procedure
timeFrame: 3 months
measure: Assessing the changes in abnormal exposure to esophageal acid induced by the procedure
timeFrame: 3 months
measure: Evaluating the impact of this technique on patients' quality of life;
timeFrame: 2 months
measure: Evaluating the impact of this technique on patients' quality of life;
timeFrame: 4 months
measure: Evaluating the impact of this technique on patients' quality of life;
timeFrame: 6 months
measure: Evaluating the impact of this technique on patients' quality of life;
timeFrame: one year
measure: Evaluating the impact of this technique on patients' quality of life;
timeFrame: 2 months
measure: Evaluating the impact of this technique on patients' quality of life;
timeFrame: 4 months
measure: Evaluating the impact of this technique on patients' quality of life;
timeFrame: 6 months
measure: Evaluating the impact of this technique on patients' quality of life;
timeFrame: one year
measure: Documenting the adverse events of the technique;
timeFrame: one year
Other outcomes:
Locations:
city: Marseille
country: France
facility: AP-HM
Study officials:
References: