ENDO-AID Assisted Tandem Colonoscopy RCT

Colorectal Neoplasms Clinical Trial

Official title:

Assessment of Efficacy of ENDO-AID Assisted Colonoscopy in Adenoma Detection: a Single Centre Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05013125
• Other study ID #: CREC.2021.336
• Status: Completed
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: April 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: April 30, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Diagnostic Test:
• ENDO-AID CADe assisted Colonoscopy
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.

Locations

Country	Name	City	State
Hong Kong	Department of Surgery, Chinese University of Hong Kong	Shatin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	End of study, about 1 year
Secondary	Polyp missed rate	To compare the Polyp missed rate (PMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. PMR is defined as the number of polyps detected in the second pass colonoscopy divided by the total number of polyps detected in both passes for the same patients.	End of study, about 1 year
Secondary	Adenoma detection rate	To compare the Adenoma detection rate (ADR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy for the first pass colonoscopy. ADR is defined as the proportion of patients with at least 1 adenoma detected in the first pass colonoscopy.	End of study, about 1 year
Secondary	Patient missed rate	To compare the patient missed rate (PMR) between ENDO-AID assisted colonoscopy and conventional white light colonoscopy. PMR is defined as the number of patients in whom adenomas were detected for the first time during second pass colonoscopy divided by the number of patients with at least 1 adenoma detected.	End of study, about 1 year
Secondary	Number of polyps removed	To compare the number of polyps removed between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy	End of study, about 1 year
Secondary	Baseline Parameters	Baseline Parameters will be compared, including withdrawal time and Boston Bowel Preparation Scale in the first colonoscopy procedures	End of study, about 1 year
Secondary	Serious Adverse Events	To compare the Serious Adverse Events between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy	At 30 days
Secondary	Number of CAD assisted abnormality	Number of abnormalities highlighted on ENDO-AID and actual number of abnormalities found macroscopically and histologically	End of study, about 1 year