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

Not Applicable

Not yet recruiting

• Conditions: Gastrointestinal Neoplasm

• Registration Number: NCT06726798
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study Start: 2024-12-09
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
R0 resection rate	30 days	Rate of complete en bloc, one-piece resection with histologically-confirmed tumour-free lateral and vertical margins

Secondary Outcome Measures

Name	Time	Method
Rate of procedural haemorrhage	30 days	Hemorrhage at the resection site that requires transfusion, discontinuation of the procedure, or adjunctive open surgical control of haemorrhage, subcategorized by: Bleeding during the index procedure, or bleeding that occurs after the subject has left the procedure room after the index procedure.
Rate of adjunctive procedure requirement	30 days	Need of adjunctive procedures, during study procedure required to control bleeding (e.g. clips or haemostatic agents)
All cause mortality rate	up to 5 years	Mortality rate after procedure
Rate of infection	up to 12 months	Clinical sepsis with changes in inflammatory markers (WCC, CRP, temperature)
Duration of procedure	1 day	Total time of ESD procedure
Length of hospital stay	3 months	Length of hospital stay (in days)

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong