Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comparison of ADR.
- Who it may be relevant to
- Registry conditions: Adenoma Detection Rate, Colonoscopy. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Colonoscopy Adenoma Detection Metrics by Extending the Screening-only Measurement to All Indications: a Prospective Multicenter Study
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.
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.
Interventions
- 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.
Primary outcome measures
- Adenoma detection rate [Time frame: 7 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Taiwan · 5 centers
- E-Da Dachang Hospital — Kaohsiung City
- E-Da Hospital — Kaohsiung City
- Keelung Chang Gung Memorial Hospital — Keelung
- Evergreen General Hospital — Taoyuan
- Linkou Chang Gung Memorial Hospital — Taoyuan
United States · 1 center
- Sepulveda Ambulatory Care Center, VAGLAHS — North Hills
Publications
- 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. PMID 24246797
- 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. PMID 33618027
- 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. PMID 28753699
- 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. PMID 33895358
Identifiers
NCT: NCT05125939 · EGH-2022-1