Prospective Cohort Study on the Safety and Efficacy of Endorobotics for Endoscopic Submucosal Dissection (Endorobotics ESD)

Prospective Cohort Study on the Safety and Efficacy of Endorobotics for Endoscopic Submucosal Dissection (Endorobotics ESD)

This trial is a prospective, single arm study of 30 patients recruited to undergo endoscopic submucosal dissection (ESD) with a novel robotic assisted technology. It will assess the safety and performance of robotic-assisted endoscopic submucosal dissection (ESD) of superficial gastric and colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques. The primary outcome of the study is rate of complete (R0) resection of the neoplasia.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.