ENDO-AID Assisted Tandem Colonoscopy RCT

Chinese University of Hong Kong360 enrolled

Overview

This study hypothesizes that more adenomas will be detected using the ENDO-AID assisted Colonoscopy compared to conventional colonoscopy. A single-centre, randomized, same-day, back-to-back tandem colonoscopy trial comparing Adenoma Missed Rate and Adenoma Detection Rate in ENDO-AID assisted colonoscopy and conventional colonoscopy.

Colorectal cancer is the third common cancer in the world and the commonest cancer in Hong Kong. Most sporadic colorectal cancers arise from benign polyps via adenoma-carcinoma sequence or the serrated polyp-carcinoma sequence. There are reports of unexpectedly high risk of interval carcinomas, as high as up to 9%, raising concerns about the effectiveness of colonoscopy in preventing colorectal cancers. Different techniques have been described to improve the area of mucosa visualised but lesions may still be missed due to failure of identification by the endoscopist. Computer Aided diagnosis (CAD) assisted colonoscopy is becoming increasingly popular to address human error. Deep learning technology has surpassed human learning and advancement in technology now allows real-time Artificial Intelligence to assist colonoscopists in polyp detection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

360

Conditions

Colorectal Neoplasms

Interventions

ENDO-AID CADe assisted ColonoscopyDIAGNOSTIC_TEST

ENDO-AID is a dedicated endoscopy Computer-Aided Diagnosis (CADe) system where suspicious lesions are automatically detected and highlighted on the main monitor in real-time, alerting the endoscopist during the procedure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18years or above * Referred to endoscopy unit for diagnostic or surveillance colonoscopy Exclusion Criteria: * Familial history of Familial adenomatous polyposis / Hereditary non-polyposis colorectal cancer * Known history of inflammatory bowel disease * Known colitis or suspicion of colitis (inflammatory bowel disease, diverticulitis, infective colitis) * Emergency endoscopy of any nature (eg gastrointestinal bleeding, colonic decompression) * Previous incomplete colonoscopy (not including insufficient preparation) / difficult colonoscopy * Patients referred for a therapeutic procedure or assessment of a known non-resected lesion * Patients with known palliative colorectal malignancy * Patient with coagulopathy * Patient with colostomy * Patient with multiple co-morbidities (American Society of Anaesthesiologist \>3) * Inability to give informed consent

Locations (1)

Department of Surgery, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Outcomes

Primary Outcomes

Adenoma missed rate

To compare the adenoma missed rate (AMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. AMR is defined as the number of adenomas detected in the second pass colonoscopy divided by the total number of adenomas detected in both passes for the same patients.