即将开始 NCT07486180

新型腔内机械人系统应用于结直肠内镜黏膜下剥离术

结直肠癌不适用I 期II 期

经自然腔道进行的腔内手术是治疗泌尿道及胃肠道(GI)良性病灶及早期癌症的有效「无切口」治疗方法。然而,目前的做法受限于使用基本手术器械,缺乏灵巧性,亦无法有效进行组织牵拉及提供三角操作。

适应症:Early Rectal Neoplasms

入组条件

纳入标准

  • 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

排除标准

  • 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.)

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。