Efficacy and safety of endoscopic cardia constriction ligation with a single-use endoscope versus a reusable endoscope for refractory gastroesophageal reflux disease: protocol for a multicenter randomized controlled trial.

BACKGROUND AND AIMS: Reusable endoscopes require reprocessing and may carry potential concerns regarding cross-contamination, whereas single-use endoscopes may reduce infection-related risks and simplify workflow. However, evidence remains limited on whether single-use endoscopes can provide comparable performance in therapeutic upper gastrointestinal procedures requiring stable visualization, reliable suction, retroflexion, and accessory compatibility. Endoscopic cardia constriction with ligation (ECCL) is a minimally invasive endoscopic treatment for refractory gastroesophageal reflux disease (GERD). This multicenter randomized controlled trial aims to compare the efficacy, safety, and procedural feasibility of ECCL performed with a single-use endoscope versus a reusable endoscope in patients with refractory GERD.

METHODS

This is a multicenter, open-label, parallel-group, non-inferiority randomized controlled trial. Ninety-eight adults aged 18-80 years with refractory GERD will be randomized 1:1 to undergo ECCL using either a single-use endoscope or a reusable endoscope. Eligible participants must have typical GERD symptoms for at least 6 months, persistent symptoms despite optimized acid-suppressive therapy, and objective evidence supporting GERD diagnosis. ECCL will be performed according to a standardized protocol. Participants will receive standardized post-procedural acid-suppressive therapy for 2 weeks and will be followed at 3 and 6 months. The primary efficacy endpoint is clinically significant symptom improvement, defined as a decrease in GERD-Q score of ≥4 points from baseline. Change in GERD-Q score will also be analyzed as a continuous supportive outcome. Secondary endpoints include procedural feasibility, safety outcomes, operational stability, device malfunction/defect rates, and acid-suppressive medication use after ECCL, including complete discontinuation of PPI/P-CAB therapy at 3 and 6 months.

DISCUSSION: This trial will provide prospective evidence on whether single-use endoscopes can support ECCL with efficacy, safety, and procedural feasibility comparable to reusable endoscopes. By integrating patient-reported outcomes, standardized procedural assessment, device-related events, and post-procedural medication use, this study may inform future clinical application of single-use endoscopes in therapeutic upper gastrointestinal endoscopy.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT07176221.