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| Name | Class |
|---|---|
| E-DA Hospital | OTHER |
| E-Da Dachang Hospital | UNKNOWN |
| Chang Gung Memorial Hospital | OTHER |
| Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Surveillance indication | Surveillance indication includes patients with prior colon neoplasms, including conventional adenomas and clinically significant serrated polyps. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate | The proportion of participants undergoing a complete colonoscopy who have one or more adenomas detected | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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All patients aged ≥50 years undergoing screening, surveillance, diagnostic, and FIT+ colonoscopy are eligible for enrollment in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi-Liang Cheng | Contact | 0919768058 | chiliang.cheng@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chi-Liang Cheng | Evergreen General Hospital, Taoyuan, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sepulveda Ambulatory Care Center, VAGLAHS | Active, not recruiting | North Hills | California | 91343 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24246797 | Result | 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. | |
| 33618027 | Result | 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. |
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| UNKNOWN |
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| E-Da Dachang Hospital |
| Not yet recruiting |
| Kaohsiung City |
| 80784 |
| Taiwan |
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| E-Da Hospital | Not yet recruiting | Kaohsiung City | 82445 | Taiwan |
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| Keelung Chang Gung Memorial Hospital | Not yet recruiting | Keelung | 204 | Taiwan |
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| Evergreen General Hospital | Recruiting | Taoyuan | 320 | Taiwan |
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| Linkou Chang Gung Memorial Hospital | Not yet recruiting | Taoyuan | 333 | Taiwan |
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| 28753699 | Result | 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. |
| 33895358 | Result | 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. |