Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07411118
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07411118
Study Brief:
Protocol Section:
NCT07411118