招募中 NCT07411118

EFTR與STER治療GIST的隨機對照試驗

食道癌不適用

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。