Role of Computer-Aided Detection Colonoscopy in Polyp Detection Rate

NCT07171333 | Completed

• 1 other identifier: OSMAMI-15/09/2022-0042892-U
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 1

Brief Summary

High-definition (HD) colonoscopy is the gold standard for early diagnosis and treatment of lower gastrointestinal neoplasms, with the adenoma detection rate (ADR) serving as a key quality indicator due to its inverse correlation with colorectal cancer incidence. ADR is influenced by operator expertise, fatigue, and human error, which may be mitigated by advanced imaging technologies such as computer-aided detection (CADe). CADe systems provide real-time visual and auditory alerts for suspected polyps and have been shown to increase ADR, though their effectiveness under different operator conditions (high- vs. low-volume, fatigue-related performance, impact on polyp detection rate \[PDR\] and withdrawal time) remains unclear. This multicenter, prospective, national, open-label randomized trial (6 Italian centers) will compare HD-Iscan colonoscopy with and without CADe assistance (1:1 allocation), with primary endpoint ADR and secondary endpoints including PDR, withdrawal time, and performance stratified by operator fatigue. Eligible patients (aged 40-80, undergoing screening, surveillance, or diagnostic colonoscopy) will be recruited consecutively, with exclusions for prior colonic resection, recent diverticulitis, inflammatory bowel disease, familial polyposis, inadequate bowel preparation, complete colonoscopy within 5 years, inability to consent, or unsafe ongoing antithrombotic therapy. Colonoscopies will follow ESGE guidelines with standard split-dose PEG preparation; all polyps will be resected and documented. Operator allocation to high- (≥200 colonoscopies/year) or low-volume (\<200/year) groups will follow routine clinical scheduling, with stratified analyses performed. The trial involves no investigational drugs or additional invasive procedures, and no adverse events are anticipated beyond those inherent to colonoscopy.

Conditions

Colorectal Polyps

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate

  Adenoma detection rate (ADR) is the percentage of patients with at least one histologically proven adenoma or carcinoma

  2 weeks

Study Arms (2)

CADe+

EXPERIMENTAL

colonoscopy with CADe system

Device: Colonoscopy with CADe system

CADe-

NO INTERVENTION

colonoscopy without CADe system

Interventions

Colonoscopy with CADe system DEVICE

Patients in the CADe+ arm underwent colonoscopy with CADe DISCOVERY™ (PENTAX Medical, Tokyo, Japan), an AI-driven tool highlighting suspected lesions in real-time, through a light-blue box. The final lesion characterization remained the endoscopist's responsibility.

CADe+

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-80 years, any sex
• Indication for screening, surveillance, or diagnostic colonoscopy (e.g., anemia, abdominal symptoms)
• Written informed consent

You may not qualify if:

• Previous (even partial) colon resection or colonic stenosis
• Acute diverticulitis within 4 weeks
• Inflammatory bowel disease, familial adenomatous polyposis, or microscopic colitis
• Complete colonoscopy within 5 years
• Inadequate suspension of antithrombotic/antiplatelet therapy (per ESGE guidelines)
• Inability to provide consent
• Inadequate bowel preparation (Boston Bowel Preparation Scale \<2 in any segment)

Sponsors & Collaborators

• Gian Eugenio Tontini: lead
• Pentax Medical: collaborator

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Gian Eugenio Tontini, MD, PhD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 12, 2025
• Study Start: August 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

IT (1)