NCT07411118 RCT of EFTR Versus STER for GIST Treatment
| NCT ID | NCT07411118 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Small Size Gastrointestinal Stromal Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2032-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2025-02-01 with a primary completion date of 2032-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Endoscopic resection has been increasing utilized as the treatment for small size gastrointestinal stromal tumors (GIST), of which the best resection method has not been identified. We aim to compare the outcomes of endoscopic full thickness resection (EFTR) versus submucosal tunnelling endoscopic resection (STER) for clinical small gastric GIST. We hypothesize that EFTR could achieve better complete margin negative resection than STER without increase in adverse event. This is an international multi-center double blinded randomized controlled trial involving four high volume centers from Hong Kong, mainland China, India and Japan. Adult patients with clinical 1.0-3.Scm gastric GIST undergoing endoscopic resection would be recruited. Patients would be randomized to undergo EFTR (intervention) or STER (Control) by expert endoscopists under general anaesthesia according to well published methods.
Eligibility 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)
Contact & Investigator
Hon Chi Yip
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT07411118 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Small Size Gastrointestinal Stromal Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07411118 currently recruiting?
Yes, NCT07411118 is actively recruiting participants. Contact the research team at hcyip@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT07411118 trial being conducted?
This trial is being conducted at Shanghai, China, Hong Kong, Hong Kong, Hyderabad, India, Osaka, Japan.
Who is sponsoring the NCT07411118 clinical trial?
NCT07411118 is sponsored by Chinese University of Hong Kong. The principal investigator is Hon Chi Yip at Chinese University of Hong Kong. The trial plans to enroll 136 participants.