Adenoma Detection Rate (ADR) Irrespective of Indication Is Comparable to Screening ADR: Implications for Quality Monitoring.
Tonya Kaltenbach, Andrew Gawron, Craig S Meyer...
https://pubmed.ncbi.nlm.nih.gov/33618027/Actively Recruiting
Led by Evergreen General Hospital, Taiwan · Updated on 2025-08-07
2700
Participants Needed
6
Research Sites
13 weeks
Total Duration
Researchers are evaluating whether the overall adenoma detection rate ADR can be a reliable alternative to the screening ADR in colonoscopy procedures. This prospective multicenter study involves 18 colonoscopists from five hospitals in Taiwan and plans to recruit 2,700 participants aged 50 to 80 years over two years. The study includes patients undergoing colonoscopy for screening, surveillance, diagnostic reasons, or positive fecal immunochemical test FIT results. The goal is to compare ADRs across these groups and explore correlations between screening ADR and overall ADR including or excluding FIT-positive cases. Participants will be grouped based on their colonoscopy indication screening asymptomatic with no or negative prior colonoscopy, surveillance with prior colon neoplasms, diagnostic symptomatic or abnormal test findings, and FIT-positive positive FIT results regardless of recent colonoscopy. The study will compare ADRs using traditional screening definitions and combined indications, including the impact of adding FIT-positive patients to overall ADR calculations. During the study, participants will undergo colonoscopy according to their indication. Researchers will measure the adenoma detection rate within 7 days as the primary outcome. Data collection will include categorizing patients and analyzing ADR correlations. The study will monitor participants throughout the procedure and follow-up as needed, with a total study duration of two years and study completion planned by September 2026.
CONDITIONS
Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study
C
Chi-Liang Cheng
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Evergreen General Hospital, Taiwan
Lead Sponsor
E-DA Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants undergo colonoscopy for different indications including screening, surveillance, diagnostic symptoms, or positive fecal immunochemical test (FIT+). This evaluation helps in detecting adenomas.
1 colonoscopy visit
Duration - Up to 2 years
Participants are observed following colonoscopy to assess adenoma detection rates across different indication categories over time.
Follow-up assessments may occur as part of routine care
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Tonya Kaltenbach, Andrew Gawron, Craig S Meyer...
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https://pubmed.ncbi.nlm.nih.gov/28753699/Charles J Kahi, Krishna C Vemulapalli, Cynthia S Johnson...
https://pubmed.ncbi.nlm.nih.gov/24246797/Uri Ladabaum, John Shepard, Ajitha Mannalithara
https://pubmed.ncbi.nlm.nih.gov/33895358/Evergreen General Hospital, Taiwan
Lead Sponsor
E-DA Hospital
Collaborating Sponsor