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

NCT05125939 | Recruiting

• 1 other identifier: EGH-2022-1
• Study Type: observational
• Target: 2,700
• Locations: 2 countries
• Sites: 6

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.

Conditions

Adenoma Detection Rate; Colonoscopy

Keywords

Colonoscopy; Adenoma detection rate; Screening

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  The proportion of participants undergoing a complete colonoscopy who have one or more adenomas detected

  7 days

Study Arms (4)

Screening indication

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.

Other: Comparison of ADR

Surveillance indication

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

Other: Comparison of ADR

Diagnostic indication

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.

Other: Comparison of ADR

Positive fecal immunochemical test

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.

Other: Comparison of ADR

Interventions

Comparison of ADR OTHER

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.

Diagnostic indication; Positive fecal immunochemical test; Screening indication; Surveillance indication

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• consecutive patients aged ≥50 years undergoing colonoscopy are eligible for enrollment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evergreen General Hospital, Taiwan: lead
• E-DA Hospital: collaborator
• E-Da Dachang Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System: collaborator

Study Sites (6)

Sepulveda Ambulatory Care Center, VAGLAHS

North Hills, California, 91343, United States

ACTIVE NOT RECRUITING

E-Da Dachang Hospital

Kaohsiung City, 80784, Taiwan

NOT YET RECRUITING

E-Da Hospital

Kaohsiung City, 82445, Taiwan

NOT YET RECRUITING

Keelung Chang Gung Memorial Hospital

Keelung, 204, Taiwan

NOT YET RECRUITING

Evergreen General Hospital

Taoyuan District, 320, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

NOT YET RECRUITING

Related 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. Epub 2013 Nov 15.

  PMID: 24246797 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Chi-Liang Cheng

  Evergreen General Hospital, Taoyuan, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Liang Cheng

CONTACT

0919768058; chiliang.cheng@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2021
• First Posted: November 18, 2021
• Study Start: November 20, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

US (1); TW (5)