Antireflux mucosal valvuloplasty versus proton pump inhibitors for the treatment of patients with gastro-oesophageal reflux disease in a tertiary healthcare centre in China: study protocol for a randomised controlled trial

INTRODUCTION: Endoscopic antireflux therapy has shown promising potential in the treatment for gastro-oesophageal reflux disease (GERD). However, there is currently no universally accepted standard for endoscopic surgery. Therefore, we introduced antireflux mucosal valvuloplasty (ARMV), an innovative endoscopic treatment for GERD. We have conducted a cohort study to assess the association between ARMV and clinical outcomes, including risks and benefits. The objective of this trail is to compare the efficacy of ARMV with proton pump inhibitors (PPIs) therapy. METHODS AND ANALYSIS: 74 patients with chronic GERD will be randomised (1:1) to undergo either ARMV or continue PPI therapy. The primary endpoint is the GERD health-related quality of life score, measured 6 months postprocedure. Secondary endpoints include the GERD questionnaire score, presence of reflux oesophagitis, appearance of the mucosal flap, DeMeester score, PPI usage and the incidence of adverse events. After 6 months, crossover is allowed for the PPI group. Assessments will occur at baseline and at 3, 6, 12, 24 and 36 months postintervention. ETHICS AND DISSEMINATION: The study protocol has been approved by the Institutional Review Board of Qilu Hospital, Shandong University. Study results will be disseminated through peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT06348420).