Comparing Treatment Effects of Gastric Peroral Endoscopic Pyloromyotomy and PEG-J in Adults with Refractory Gastroparesis

What this Trial Is About

Researchers are conducting a randomized, non-blinded clinical trial to compare two treatments for patients with gastroparesis GP that does not respond to standard therapies. The study focuses on 50 patients who have already tried dietary advice, prokinetics, and possibly tube feeding, and who have been referred for additional treatment options. The purpose is to evaluate which treatment shows better success in improving symptoms, using the Gastroparesis Cardinal Symptom Index GCSI score as a key measure six months after treatment. Participants are randomly assigned to one of two groups one group receives Gastric Per-Oral Endoscopic Pyloromyotomy G-POEM, a procedure targeting the pylorus, and the other group receives a Percutaneous Endoscopic Gastrostomy with Jejunal Extension PEG-J, a feeding tube method. The study allows for a possible crossover after six months of follow-up. The main goal is to see how many patients achieve a meaningful improvement defined as a decrease of 1 or more points in the GCSI score. Additional outcomes include quality of life assessments and monitoring of adverse events over 12 months. During the study, participants will be assessed at baseline and six months after intervention, with some outcomes also measured at 12 months. Evaluations include symptom scoring with the GCSI, quality of life questionnaires PAGI-QOL, and safety monitoring for any serious adverse events. The study will also explore how the underlying cause of gastroparesis may influence treatment success. Overall participation will last at least 12 months with regular follow-up to collect these data.

G-POEM vs PEG-J in Gastroparesis Patients