本试验为一项前瞻性单臂研究,招募30名患者接受采用新型机械人辅助技术的内镜黏膜下剥离术(ESD)。研究将评估机械人辅助内镜黏膜下剥离术(ESD)治疗表浅胃癌及结直肠病灶的安全性及表现,该等病灶无法以圈套器技术达到最佳及根治性切除。
适应症:Gastrointestinal Neoplasm
入组条件
纳入标准
- 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.
排除标准
- 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.
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。