ENDO-AID Assisted Tandem Colonoscopy RCT

The Chinese University of Hong Kong

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Diagnostic Test: ENDO-AID CADe assisted Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05013125

CREC.2021.336

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

360 participants in 2 patient groups

Conventional Colonoscopy - ENDO-AID assisted Colonoscopy

No Intervention group

Description:

Patients will undergo usual colonoscopy as per usual practice, followed back to back by ENDO-AID assisted colonoscopy

ENDO-AID assisted Colonoscopy - ENDO-AID assisted Colonoscopy

Active Comparator group

Description:

Patients will undergo ENDO-AID assisted colonoscopy with all polyps treated as per usual practice, followed back to back by ENDO-AID assisted colonoscopy

Treatment:

Diagnostic Test: ENDO-AID CADe assisted Colonoscopy