Endoscopic procedure for treating severe gastroesophageal reflux
Anti-Reflux Mucosectomy (ARMS) in the Treatment of Refractory Gastro-esophageal Reflux (GERD): a Prospective Randomized Comparative Study
This study is testing a new endoscopic procedure called anti-reflux mucosectomy to see if it can help people with severe gastroesophageal reflux disease who haven't found relief from regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT05745012 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of anti-reflux mucosectomy (ARMS) in patients with refractory gastroesophageal reflux disease (GERD) who have not responded to standard medical treatments. The study involves a randomized, blinded comparison of ARMS against a sham procedure and conventional medical follow-up. The ARMS technique utilizes a mucosal ligation system to achieve endoscopic fundoplication, aiming to improve symptoms and quality of life for patients suffering from persistent GERD. Previous studies have indicated a symptom resolution rate of approximately 65-70%, making this a promising intervention for eligible patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with refractory GERD symptoms persisting despite optimized medical treatment.
Not a fit: Patients with severe esophagitis or other significant esophageal conditions may not benefit from this procedure.
Why it matters
Potential benefit: If successful, this procedure could significantly improve the quality of life for patients suffering from refractory GERD.
How similar studies have performed: Previous studies have shown promising results with similar techniques, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Marseille
- Ap-Hm — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Jean-Michel Gonzalez, MD
- Email: jean-michel.gonzalez@ap-hm.fr
- Phone: 0491368737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.