Role of Computer-Aided Detection Colonoscopy in Polyp Detection Rate

NCT ID: NCT07171333

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 421 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CADe+

colonoscopy with CADe system

Group Type: EXPERIMENTAL

Colonoscopy with CADe system

Intervention Type: 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-

colonoscopy without CADe system

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Colonoscopy with CADe system

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pentax Medical

INDUSTRY

Sponsor Role: collaborator

Gian Eugenio Tontini

OTHER

Sponsor Role: lead

Responsible Party

Gian Eugenio Tontini

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gian Eugenio Tontini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Countries

Italy

Other Identifiers

OSMAMI-15/09/2022-0042892-U

Identifier Type: -

Identifier Source: org_study_id