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

Colonoscopy Clinical Trial

Official title:

Improving Colonoscopy Adenoma Detection Metrics by Extending the Screening-only Measurement to All Indications: a Prospective Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05125939
• Other study ID #: EGH-2022-1
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Detection Rate
• Colonoscopy

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