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| ID | Type | Description | Link |
|---|---|---|---|
| MHWFA A092230 | Other Grant/Funding Number | Ministry of Health, Welfare & Family Affairs, Korea |
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| Name | Class |
|---|---|
| National Cancer Center, Korea | OTHER_GOV |
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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The investigators plan to conduct a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal polyp. This study will be performed using web-based research network, e-VELOS in Korea.
Various endoscopic tools have been tried to reduce polyp missing rate which has been reported to be 20-25%. Transparent cap-assisted colonoscopy has been suggested to improve visualization of the lesion that are difficult to access, such as tangentially located lesions and those located within a limited luminal space. Chromoendoscopy with indigocarmine spraying was reported to increases the detection rates of polyp, especially in right colon and rectum. However, there also have been mixed results regarding polyp detection rates of the endoscopic methods. Moreover, there is no data regarding the impact of the screening tools on longterm recurrence rate of colorectal polyp. Therefore, in this study, we intend to perform a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal polyps. This study will be performed using web-based research network, e-VELOS in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cap-assisted chromoendoscopy | Experimental | To the tip of the colonoscope, transparent cap is fitted and applied. In addition, panchromoendoscopy using indigocarmine solution is preformed in this group. |
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| Standard colonoscopy | No Intervention | Neither transparent cap nor chromoendoscopy is applied in this group and standard colonoscopy is performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cap-assisted chromoendoscopy | Device | A cap (irrigation cap) is a simple plastic device that can be attached to the tip of a colonoscope before performing the colonoscopy. For chromoendoscopy, 0.09% indigocarmine was administered via irrigation cap . |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate | The proportion of subjects with at least one adenoma | 7 days is needed to confirm the pathologic examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Proximal adenoma detection rate | Proportion of subjects with at least one proximal colon adenoma | 7 days is needed to confirm the pathologic examination. |
| Proximal serrated polyp detection rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyun Soo Kim | Korean Association for the Study of Intestinal Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Medical Center | Anyang | South Korea | ||||
| Kosin University College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31972618 | Derived | Kim SY, Park HJ, Kim HS, Park DI, Cha JM, Park SJ, Choi H, Shin JE, Eun CS, Kim JO, Kim HG, Kim SE, Park CH, Kim TI, Hong SN. Cap-Assisted Chromoendoscopy Using a Mounted Cap Versus Standard Colonoscopy for Adenoma Detection. Am J Gastroenterol. 2020 Mar;115(3):465-472. doi: 10.14309/ajg.0000000000000510. |
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Proportion of subjects with at least one proximal serrated polyp/adenoma
| 7 days is needed to confirm the pathologic examination. |
| Advanced adenoma detection rate | Proportion of subjects with at least one advanced adenoma | 7 days is needed to confirm the pathologic examination. |
| Serrated adenoma detection rate | Proportion of subjects with at least one serrated adenoma | 7 days is needed to confirm the pathologic examination. |
| Cancer detection rate | Proportion of subjects with at least one cancer | 7 days is needed to confirm the pathologic examination. |
| Surveillance | Surveillance interval recommendations for both groups were classified based on adenoma detection | 7 - 14 days |
| Busan |
| South Korea |
| Dankuk University college of medicine hospital | Cheonan | South Korea |
| National Cancer Center Hospital, National Cancer Center | Goyang | South Korea |
| Hanyang University Guri Hospital, Hanyang University College of Medicine | Guri-si | South Korea |
| Catholic university St. Mari's hospital | Incheon | South Korea |
| Asan Medical Center, University of Ulsan College of Medicine | Seoul | South Korea |
| Ewha Mokdong hospital | Seoul | South Korea |
| Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine | Seoul | South Korea |
| Samsung Medical Center, Sungkyunkwan University School of Medicine | Seoul | South Korea |
| Sunchunhyang University hospital | Seoul | South Korea |
| Sungkyunkwan University Kangbuk Samsung hospital | Seoul | South Korea |
| Yonsei University College of Medicine | Seoul | South Korea |
| Yonsei Uiniversity Wonju College of Medicine | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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