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。