招募中 NCT07411118

EFTR与STER治疗GIST的随机对照试验

食管癌不适用

内镜切除术已日益广泛应用于小型胃肠道基质瘤(GIST)的治疗,惟最佳切除方法尚未确定。本研究旨在比较内镜全层切除术(EFTR)与黏膜下隧道内镜切除术(STER)治疗临床小型胃GIST的疗效。

适应症:Small Size Gastrointestinal Stromal Tumors、GIST

入组条件

纳入标准

  • 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)

排除标准

  • 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)

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。