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Recruiting nowN/AAges 18 Years to 75 Years

RCT of EFTR Versus STER for GIST Treatment

Sponsor: Chinese University of Hong Kong · NCT07411118 on ClinicalTrials.gov ↗

Conditions studied

Small Size Gastrointestinal Stromal TumorsGIST

What it tests

  • Endoscopic full thickness resection (EFTR) / Exposed non-tunneling EFTRprocedure
  • Submucosal Tunneling Endoscopic Resection (STER) / Exposed tunneling EFTRprocedure

Where it's running4 sites

4 international sites
  • Department of Gastroenterology, Zhongshan Hospital of Fudan University

    Shanghai, China

    Opening soon
  • Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong

    Hong Kong, Hong Kong

    Recruiting now
  • Asian Institute of Gastroenterology

    Hyderabad, India

    Opening soon
  • Osaka International Cancer Institute

    Osaka, Japan

    Opening soon
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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)

Updated 2026-02-13 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.