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

N/ANot Yet RecruitingNCT06726798

Chinese University of Hong Kong30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastrointestinal Neoplasm

Interventions

Endoscopic submucosal dissection with EndoRobotics traction devicePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

R0 resection rate

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

Time frame: 30 days

Secondary Outcomes

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.

Time frame: 30 days

Rate of adjunctive procedure requirement

Need of adjunctive procedures, during study procedure required to control bleeding (e.g. clips or haemostatic agents)

Time frame: 30 days

All cause mortality rate

Mortality rate after procedure

Time frame: up to 5 years

Rate of infection

Clinical sepsis with changes in inflammatory markers (WCC, CRP, temperature)

Time frame: up to 12 months

Duration of procedure

Total time of ESD procedure

Time frame: 1 day

Length of hospital stay

Length of hospital stay (in days)

Time frame: 3 months

Central Contacts

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

CONTACT

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

Data from ClinicalTrials.gov

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