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OpenTrials
Completed

NCT Number: NCT07171333

Role of Computer-Aided Detection Colonoscopy in Polyp Detection Rate

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.

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Key information

Conditions

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Adenoma Detection Rate

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

Gian Eugenio Tontini

Other

Collaborators

  • Pentax Medical

Registry information

Official study title

Role of Computer-Aided Detection Colonoscopy in Polyp Detection Rate: an Italian Multi-Center Randomized Study (CADEC)

Acronym: CADEC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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