Comparing Endoscopic Full Thickness Resection and Submucosal Tunneling Endoscopic Resection for Small Gastric Gastrointestinal Stromal Tumors in Adults

What this Trial Is About

Researchers are evaluating two different endoscopic methods, endoscopic full thickness resection EFTR and submucosal tunneling endoscopic resection STER, for treating small gastric gastrointestinal stromal tumors GISTs between 1.0 and 3.5 cm in size. This international randomized controlled trial involves adult patients from centers in Hong Kong, mainland China, India, and Japan. The purpose is to compare the outcomes of EFTR versus STER, focusing on complete margin negative resection and adverse events, as the best method has not yet been identified. Participants will be randomly assigned to undergo either EFTR or STER performed by expert endoscopists under general anesthesia. EFTR involves direct full thickness resection of the tumor with closure of the wall defect using various clipping or suturing techniques, while STER creates a submucosal tunnel to remove the tumor and closes the mucosal incision with clips. Crossover from STER to EFTR is allowed if needed to achieve tumor resection. Both procedures follow well-established methods and aim for en-bloc tumor removal. During the study, participants will undergo diagnostic endoscopy, endoscopic ultrasound, and CT scans to assess eligibility. Researchers will measure primary outcomes like complete R0 resection within 1 day, and secondary outcomes including procedure times, adverse event rates, recurrence within 30 days, patient pain scores, procedural difficulty, and surgical conversion rates. Follow-up assessments will monitor safety and tumor recurrence, with the total study duration extending up to the study end date in 2033.

RCT of EFTR Versus STER for GIST Treatment