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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05125939
Other study ID # EGH-2022-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 20, 2021
Est. completion date August 31, 2025

Study information

Verified date April 2024
Source Evergreen General Hospital, Taiwan
Contact Chi-Liang Cheng
Phone 0919768058
Email chiliang.cheng@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2700
Est. completion date August 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Taiwan 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
United States Sepulveda Ambulatory Care Center, VAGLAHS North Hills California

Sponsors (5)

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

Countries where clinical trial is conducted

United States,  Taiwan, 

References & Publications (4)

Kahi CJ, Vemulapalli KC, Johnson CS, Rex DK. Improving measurement of the adenoma detection rate and adenoma per colonoscopy quality metric: the Indiana University experience. Gastrointest Endosc. 2014 Mar;79(3):448-54. doi: 10.1016/j.gie.2013.10.013. Epu — View Citation

Kaltenbach T, Gawron A, Meyer CS, Gupta S, Shergill A, Dominitz JA, Soetikno RM, Nguyen-Vu T, A Whooley M, Kahi CJ. Adenoma Detection Rate (ADR) Irrespective of Indication Is Comparable to Screening ADR: Implications for Quality Monitoring. Clin Gastroent — View Citation

Ladabaum U, Shepard J, Mannalithara A. Adenoma and Serrated Lesion Detection by Colonoscopy Indication: The ADR-ESS (ADR Extended to all Screening/Surveillance) Score. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1873-1882. doi: 10.1016/j.cgh.2021.04.027. E — View Citation

Rex DK, Ponugoti PL. Calculating the adenoma detection rate in screening colonoscopies only: Is it necessary? Can it be gamed? Endoscopy. 2017 Nov;49(11):1069-1074. doi: 10.1055/s-0043-113445. Epub 2017 Jul 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Adenoma detection rate The proportion of participants undergoing a complete colonoscopy who have one or more adenomas detected 7 days
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