NCT05125939

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: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,700 (estimated)
• Sponsor: Evergreen General Hospital, Taiwan · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: —

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.

Conditions

• Adenoma Detection Rate
• Colonoscopy

Interventions

Type	Name	Description
OTHER	Comparison 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.

Timeline

• Start date: 2021-11-20
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2021-11-18
• Last updated: 2025-08-07

Locations

6 sites across 2 countries: United States, Taiwan