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Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study

Improving Colonoscopy Adenoma Detection Metrics by Extending the Screening-only Measurement to All Indications: a Prospective Multicenter Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05125939
Enrollment
2707
Registered
2021-11-18
Start date
2021-11-20
Completion date
2026-08-31
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma Detection Rate, Colonoscopy

Keywords

Colonoscopy, Adenoma detection rate, Screening

Brief summary

This is a prospective equivalence colonoscopy study evaluating whether overall adenoma detection rate (ADR) is a reliable alternate for screening ADR. Overall indication includes screening, surveillance, and diagnostic indications.

Detailed description

This multicenter study will be conducted by 18 colonoscopists from 5 hospitals in Taiwan, including Evergreen general hospital, E-da hospital, E-da Dachang hospital, Linkou Chang Gung memorial hospital, and Keelung Chang Gung memorial hospital, and plans to recruit 2700 prospective participants in a 2-year period. Felix W. Leung from Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System (USA) will be involved in the study design, and will participate in data analyses and report preparation. Consecutive patients aged ≥50 years undergoing colonoscopy are eligible for enrollment. Positive fecal immunochemical test (FIT+) is considered as an independent indication category and the colonoscopy indications are categorized into 4 groups: screening, surveillance, diagnostic, and FIT+. Overall indication will be subdivided into overall excluding FIT (overall-non-FIT) group and overall including FIT (overall-FIT) group. In this study, the investigators plan to (1) compare individual ADR across 4 colonoscopy indication categories (screening, surveillance, diagnostic, FIT+); (2) explore correlations between screening ADR and overall-non-FIT and overall-FIT ADRs, respectively.

Interventions

OTHERComparison of ADR

The investigators will compare ADRs using traditional screening-restricted definition and combined screening, surveillance, and diagnostic indication (i.e., overall-non-FIT indication). The impact of addition of FIT+ indication into the overall indication (i.e., overall-FIT indication) on ADR will also be evaluated.

Sponsors

Evergreen General Hospital, Taiwan
Lead SponsorOTHER
E-DA Hospital
CollaboratorOTHER
E-Da Dachang Hospital
CollaboratorUNKNOWN
Chang Gung Memorial Hospital
CollaboratorOTHER
Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years

Inclusion criteria

* consecutive patients aged ≥50 years undergoing colonoscopy are eligible for enrollment.

Exclusion criteria

* high risk family history of colorectal cancer (CRC) e.g., familial adenomatous polyposis, hereditary non-polyposis CRC syndrome, multiple first degree relatives with CRC, or a single first degree relative with CRC at \<60 years * serrated polyposis syndrome * inflammatory bowel disease * colonoscopy to remove a large neoplastic polyps * obstructive lesions of the colon * gastrointestinal bleeding * current participation in other studies * hospitalized patients * mental retardation * pregnancy * refusal to provide a written informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Adenoma detection rate7 daysThe proportion of participants undergoing a complete colonoscopy who have one or more adenomas detected

Countries

Taiwan, United States

Contacts

PRINCIPAL_INVESTIGATORChi-Liang Cheng

Evergreen General Hospital, Taoyuan, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026