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

Evergreen General Hospital, Taiwan

Status: Enrolling

Conditions: Colonoscopy; Adenoma Detection Rate

Treatments: Other: Comparison of ADR

Study type: Observational

Funder types: Other

Identifiers

NCT05125939

EGH-2022-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,700 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,700 participants in 4 patient groups

Screening indication

Description:

Screening indication includes asymptomatic patients aged ≥50 years with no prior colonoscopy and at average risk of CRC. Screening indication also includes asymptomatic patients with negative prior colonoscopy.

Treatment:

Other: Comparison of ADR

Surveillance indication

Description:

Surveillance indication includes patients with prior colon neoplasms, including conventional adenomas and clinically significant serrated polyps.

Treatment:

Other: Comparison of ADR

Diagnostic indication

Description:

Diagnostic indication includes patients who report symptoms (e.g., abdominal pain, a change in bowel habits, or rectal bleeding) before their first screening examination and undergo evaluation of an abnormality on other image study, unexplained anemia and/or unexplained weight loss.

Treatment:

Other: Comparison of ADR

Positive fecal immunochemical test

Description:

FIT+ indication includes patients who undergo colonoscopy for positive FIT results in screen-eligible individuals. FIT+ indication also applies to those with a positive FIT result and a recent colonoscopy.

Treatment:

Other: Comparison of ADR