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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Neoplasm
• Intervention / Treatment: Procedure: Endoscopic submucosal dissection with EndoRobotics traction device

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip Wai Yan Chiu, MBChB, FRCSEd, FHKAM, MD; Phone Number: +852 35052627; Email: philipchiu@med.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
    • Contact: Hon Chi Yip, MBChB, FRCSEd, FHKAM; Phone Number: +852 35052627; Email: hcyip@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Robotic ESD arm

Procedure: Endoscopic submucosal dissection with EndoRobotics traction device; All patients received robotic ESD under general anesthesia or monitored anaesthetic care at the endoscopy center of Prince of Wales Hospital. The targeted lesion would first be localized and pre-injected using a mixture of normal saline, indigocarmine, epinephrine and sodium hyaluronate. The robotic endoscopic traction device was then inserted to reach the target. Mucosal incision first started from the anal side followed by lifting with the grasper[Figure 1; Video 1]. Vio 3 diathermy system (ERBE, Germany) was used with endocut Q effect 3 and forced coagulation effect 3. Further submucosal dissection would be performed by electrocautery knife with traction achieved via EndoRobotics traction. Upon completion, the specimen would be retrieved upon withdrawal of the whole system.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of procedural haemorrhage	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.	30 days
Rate of adjunctive procedure requirement	Need of adjunctive procedures, during study procedure required to control bleeding (e.g. clips or haemostatic agents)	30 days
All cause mortality rate	Mortality rate after procedure	up to 5 years
Rate of infection	Clinical sepsis with changes in inflammatory markers (WCC, CRP, temperature)	up to 12 months
Duration of procedure	Total time of ESD procedure	1 day
Length of hospital stay	Length of hospital stay (in days)	3 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): December 9, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopic submucosal dissection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: CUHK EndoRobotics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No