Comparing EFTR versus STER for removing small gastric GISTs
Exposed Endoscopic Full Thickness Resection (EFTR) Versus Submucosal Tunnelling Endoscopic Resection (STER) for Small Gastric Gastrointestinal Stromal Tumor (GIST) - an International Double Blinded Randomized Controlled Trial
NA · Chinese University of Hong Kong · NCT07411118
This trial will test whether endoscopic full-thickness resection (EFTR) or submucosal tunneling endoscopic resection (STER) is better at completely removing small (1.0–3.5 cm) gastric GISTs in adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 4 sites (Shanghai and 3 other locations) |
| Trial ID | NCT07411118 on ClinicalTrials.gov |
What this trial studies
This is a multi-center, double-blinded randomized trial enrolling adults with 1.0–3.5 cm gastric GISTs judged suitable for endoscopic removal. Participants are randomly assigned to undergo EFTR or STER performed by expert endoscopists under general anesthesia using established techniques. Outcomes include complete margin-negative (R0) resection and adverse events, with follow-up to compare safety and efficacy between the two approaches. The trial is being run at high-volume centers in Hong Kong, mainland China, India, and Japan to standardize technique and capture international data.
Who should consider this trial
Good fit: Adults aged 18–75 with a single gastric subepithelial tumor 1.0–3.5 cm arising from the muscularis propria, without high-risk features and deemed feasible for either EFTR or STER, are ideal candidates.
Not a fit: Patients with tumors unsuitable for endoscopic resection (unfavorable location, high-risk morphology), multiple tumors, or lesions outside the 1.0–3.5 cm range are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could identify which endoscopic method more reliably removes small gastric GISTs with clear margins while keeping complication rates low, helping patients avoid more invasive surgery.
How similar studies have performed: Both EFTR and STER have been used successfully in observational series and case series with favorable short-term recovery, but a direct randomized head-to-head comparison like this is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Consecutive adult patients age \>=18 and \<=75 with a clinical diagnosis of gastric GIST who opted for endoscopic resection would be screened for eligibility. Inclusion Criteria: * Presence of gastric subepithelial tumor on diagnostic upper endoscopy, and * Diagnostic EUS and CT scan with intravenous contrast suspicious of GIST arising from muscularis propria layer, size with maximum diameter \>=1.0cm and \<= 3.5cm, and * Absence of high risk features, including irregular margins, invasion to surrounding organs, lesion hypervascularity, and * Endoscopic morphology and location deemed feasible with both EFTR and STER by an expert endoscopist, or * Histological confirmation of GIST through EUS guided fine needle biopsy (Optional, based on recommendation from guidelines) Exclusion Criteria: * Patients with tumors deemed not suitable for endoscopic resection (Either EFTR or STER), due to unfavourable location, high risk morphology, or any other reasons. * Patients with multiple tumors. * Patients unable or unwilling to provide consent. * Previous esophageal or gastric surgery. * Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above. * Pregnant women or those planning pregnancy or breastfeeding women. * Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl. * Patients on double anti-platelet agents or anti-coagulation (Warfarin, heparin or other direct oral anticoagulants)
Where this trial is running
Shanghai and 3 other locations
- Department of Gastroenterology, Zhongshan Hospital of Fudan University — Shanghai, China (NOT_YET_RECRUITING)
- Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)
- Asian Institute of Gastroenterology — Hyderabad, India (NOT_YET_RECRUITING)
- Osaka International Cancer Institute — Osaka, Japan (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Hon Chi Yip — Chinese University of Hong Kong
- Study coordinator: Hon Chi Yip
- Email: hcyip@surgery.cuhk.edu.hk
- Phone: +852 3505 2956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Small Size Gastrointestinal Stromal Tumors, GIST, EFTR, STER