即將開始 NCT06726798

內窺鏡機械人輔助內窺鏡黏膜下剝離術的安全性及療效前瞻性隊列研究(Endorobotics ESD)

大腸直腸癌不適用

本試驗為一項前瞻性單臂研究,招募30名患者接受採用新型機械人輔助技術的內窺鏡黏膜下剝離術(ESD)。研究將評估機械人輔助內窺鏡黏膜下剝離術(ESD)治療表淺胃癌及結直腸病灶的安全性及表現,該等病灶無法以圈套器技術達到最佳及根治性切除。

適應症:Gastrointestinal Neoplasm

收案條件

納入條件

  • Patients with endoscopic diagnosis of early gastric or colorectal neoplasia
  • Patients will be recruited according to ESGE and JGES guidelines for gastric \& colorectal ESD including: 1. Lesions for which en bloc resection with snare EMR is difficult to apply; 2. Mucosal tumors with submucosal fibrosis; 3. Sporadic tumors in conditions of chronic inflammation and 4. Local residual or recurrent early carcinomas after endoscopic resection.

排除條件

  • Informed consent not available
  • Carcinoma of colon or rectum or stomach with invasion to submucosa or beyond
  • Evidence of distant metastasis
  • Presence of another active malignancy
  • Pregnancy
  • Patients unfit for general anesthesia
  • Endoscopic platform cannot reach target lesion
  • Patients recruited into another clinical trial.

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。