即將開始 NCT07486180

新型腔內機械人系統應用於結直腸內窺鏡黏膜下剝離術

大腸直腸癌不適用I 期II 期

經自然腔道進行的腔內手術是治療泌尿道及胃腸道(GI)良性病灶及早期癌症的有效「無切口」治療方法。然而,目前的做法受限於使用基本手術器械,缺乏靈巧性,亦無法有效進行組織牽拉及提供三角操作。

適應症:Early Rectal Neoplasms

收案條件

納入條件

  • Patients diagnosed with nonpedunculated early rectal neoplasms \>/= 2 cm in size in the rectum (\>/= 3 cm and \</= 18 cm from the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or endoscopic mucosal resection (EMR) as judged by two experienced endoscopists
  • American Society of Anesthesiologists (ASA) grading I-III
  • Informed consent available

排除條件

  • Presence of endoscopic signs of massive submucosal invasion (including excavated/depressed morphology, Kudo's pit pattern Type V, or Sano's capillary pattern Type IIIB)
  • Evidence of deep invasion on endorectal ultrasonography
  • Unfavorable histopathologic features on biopsy (mucinous cancer, poor differentiation, or gross submucosal invasion)
  • Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are indicated for surgical resection
  • Patients with recurrence from previous EMR or ESD
  • Patients with non-correctable coagulopathy
  • Patients with contraindications to general anesthesia
  • Vulnerable population (e.g., mentally disabled, pregnancy.)

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。