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

Recruiting

• Conditions: Colonoscopy; Adenoma Detection Rate

• Registration Number: NCT05125939
• Lead Sponsor: Evergreen General Hospital, Taiwan

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.

Study Timeline

• Study First Submitted: 2021-11-07
• Study First Submitted QC: 2021-11-07
• Study First Posted: 2021-11-18
• Study Start: 2021-11-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2700

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	7 days	The proportion of participants undergoing a complete colonoscopy who have one or more adenomas detected

Trial Locations

Locations (6)

Sepulveda Ambulatory Care Center, VAGLAHS; 🇺🇸 North Hills, California, United States

E-Da Dachang Hospital; 🇨🇳 Kaohsiung, Taiwan

E-Da Hospital; 🇨🇳 Kaohsiung, Taiwan

Keelung Chang Gung Memorial Hospital; 🇨🇳 Keelung, Taiwan

Evergreen General Hospital; 🇨🇳 Taoyuan, Taiwan

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan