Endocuff With or Without AI-assisted Colonoscopy

Colonic Polyp Clinical Trial

Official title:

Endocuff With or Without Artificial Intelligence-assisted Colonoscopy in Detection of Colorectal Adenoma: a Randomized Colonoscopy Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133544
• Other study ID #: UW 20-647
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: February 2024

Study information

• Verified date: April 2023
• Source: The University of Hong Kong
• Contact: Ka Luen, Thomas Lui, MBBS
• Phone: 22554048
• Email: klluitc[@]yahoo.com.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Colonoscopy is considered the gold standard for diagnosis of colonic polyps. However, it was reported that colonoscopy could still miss colonic polyps. Many attempts have been made to improve the detection rate of colonoscopy. Artificial intelligence (AI) is a promising new technique to improve detection rate of colonic adenoma. However, it remains uncertain whether whether the combined use of Endocuff and AI assisted examination could help to further improve the adenoma detection rate. This is a prospective randomized trial comparing the use of endocuff with AI, AI alone or conventional colonoscopy examination on adenoma detection rate.

Description:

TThis is a prospective randomized tandem colonoscopy trial comparing three different modes of colonoscopy techniques. The first group will use Endocuff (Olympus, Hong Kong) and AI assisted colonoscopy. The second group will use AI assisted colonoscopy alone and the third group will use standard high-definition white light colonoscopy.

Eligible patients will be randomly allocated in a 1:1:1 ratio to three groups. Patients will be stratified according to indications of colonoscopy (symptomatic vs screening/surveillance).

All examination will be performed with high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Tokyo, Japan) under white light by experienced endoscopists. All endoscopists should have received training on the interpretation of real-time AI detection system as well as the Endocuff before performing study colonoscopy.

In all colonoscopy examination, colonoscope will be first advanced to the cecum as confirmed by identification of the appendiceal orifice and ileocecal valve or by intubation of the ileum. After cecal intubation is performed, the colonoscopy is first withdrawn according to the group assigned. For group 1, the first withdrawal would be done with Endocuff and AI assistance. For group 2, the first withdrawal would be done under AI assistance only. For group 3, the first withdrawal would be done under standard high definition colonoscopy only.

All detected polyps will be removed during the withdrawal only. The size (measured with biopsy forceps), location and morphology of each polyp will be recorded by an independent observer. The withdrawal time (minus the polypectomy site) will be measured by a stopwatch and with a minimum of 6 minutes. The bowel preparation quality will be graded according to the Boston Bowel Preparation Scale

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 656
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital, Tung Wah Hospital and Tuen Mun Hospital in Hong Kong will be recruited.

Exclusion Criteria:

• Patients will be excluded if they have history of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes, bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe. Moreover, after randomization, if the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is <2, these patients will be excluded

Related Conditions & MeSH terms

• Adenoma
• Colonic Adenoma
• Colonic Cancer
• Colonic Neoplasms
• Colonic Polyp
• Colonic Polyps

Intervention

Device:
• Endocuff with AI
Use of endocuff with computer assisted polyp detection
• AI alone
Use of computer assisted polyp detection

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	The proportion of patients with at least one adenomas	One month after colonoscopy
Secondary	Polyp detection rate	the proportion of patients with at least one polyp	One month after colonoscopy
Secondary	Sessile serrated adenomas detection rate	The proportion of patients with at least one sessile serrated adenomas	One month after colonoscopy
Secondary	Sessile serrated polyps detection rate	The proportion of patients with at least one sessile serrated polyps	One month after colonoscopy
Secondary	Advanced adenoma detection rates	The proportion of patients with at least one advanced adenomas	One month after colonoscopy
Secondary	Mean number of polyp per patient	The mean number of polyp per patient	One month after colonoscopy
Secondary	Mean number of adenoma per patient	The mean number of adenoma per patient	One month after colonoscopy
Secondary	Total number of polyp or adenoma per patient.	The total number of polyp or adenoma per patient.	One month after colonoscopy