Clinical trial NCT05125939: Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study
Official title: Improving Colonoscopy Adenoma Detection Metrics by Extending the Screening-only Measurement to All Indications: a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenoma Detection Rate
Colonoscopy
Keywords: Colonoscopy
Adenoma detection rate
Screening
Lead sponsor: Evergreen General Hospital, Taiwan
Sponsor class: OTHER
Collaborators: name: E-DA Hospital
name: E-Da Dachang Hospital
name: Chang Gung Memorial Hospital
name: Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System
First posted: 2021-11-18
Enrollment: 2700
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged ≥50 years undergoing screening, surveillance, diagnostic, and FIT+ colonoscopy are eligible for enrollment in this study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: North Hills
country: United States
facility: Sepulveda Ambulatory Care Center, VAGLAHS
state: California
city: Kaohsiung
country: Taiwan
facility: E-Da Dachang Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Evergreen General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Evergreen General Hospital, Taoyuan, Taiwan
name: Chi-Liang Cheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Epub 2013 Nov 15.
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 Gastroenterol Hepatol. 2021 Sep;19(9):1883-1889.e1. doi: 10.1016/j.cgh.2021.02.028. Epub 2021 Feb 19.
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.
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. Epub 2021 Apr 22.