Comparing EFTR versus STER for removing small gastric GISTs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong
  Hong Kong, Hong Kong Recruiting
• Department of Gastroenterology, Zhongshan Hospital of Fudan University
  Shanghai, China Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.