Anti-Reflux Mucosectomy in the Treatment of Refractory Gastro-esophageal Reflux (MARRGO)
Gastroesophageal Reflux Disease With Ulceration
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease With Ulceration
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
Sites / Locations
- AP-HMRecruiting
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
group A: control group
group B: ARMS procedure