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

NCT06726798 | Not Yet Recruiting

• 1 other identifier: CUHK EndoRobotics
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Neoplasm

Keywords

Endoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  Rate of complete en bloc, one-piece resection with histologically-confirmed tumour-free lateral and vertical margins

  30 days

Secondary Outcomes (6)

• Rate of procedural haemorrhage

  30 days

• Rate of adjunctive procedure requirement

  30 days

• All cause mortality rate

  up to 5 years

• Rate of infection

  up to 12 months

• Duration of procedure

  1 day

Study Arms (1)

Robotic ESD arm

EXPERIMENTAL

Procedure: Endoscopic submucosal dissection with EndoRobotics traction device

Interventions

Endoscopic submucosal dissection with EndoRobotics traction device PROCEDURE

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.

Robotic ESD arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Philip Wai Yan Chiu, MBChB, FRCSEd, FHKAM, MD

CONTACT

+852 35052627; philipchiu@med.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Faculty of Medicine

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: December 9, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

HK (1)