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

Evergreen General Hospital, Taiwan2,700 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

2,700

Conditions

Adenoma Detection Rate Colonoscopy

Interventions

Comparison of ADROTHER

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (6)

Sepulveda Ambulatory Care Center, VAGLAHS

North Hills, California, United States

ACTIVE_NOT_RECRUITING

E-Da Dachang Hospital

Kaohsiung City, Taiwan

NOT_YET_RECRUITING

E-Da Hospital

Kaohsiung City, Taiwan

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Adenoma detection rate

The proportion of participants undergoing a complete colonoscopy who have one or more adenomas detected

Time frame: 7 days

Central Contacts

Chi-Liang Cheng

CONTACT

0919768058 chiliang.cheng@gmail.com

Data from ClinicalTrials.gov

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