內窺鏡切除術已日益廣泛應用於小型胃腸道基質瘤(GIST)的治療,惟最佳切除方法尚未確定。本研究旨在比較內窺鏡全層切除術(EFTR)與黏膜下隧道內窺鏡切除術(STER)治療臨床小型胃GIST的療效。
適應症:Small Size Gastrointestinal Stromal Tumors、GIST
收案條件
納入條件
- Consecutive adult patients age \>=18 and \<=75 with a clinical diagnosis of gastric GIST who opted for endoscopic resection would be screened for eligibility.
- 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)
排除條件
- 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)
收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。