Colorectal Neoplasm
Conditions
Keywords
Colorectal neoplasm, Colonoscopy, chromoendoscopy, cap-assisted colonoscopy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEcap-assisted chromoendoscopy
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 .
Sponsors
National Cancer Center, Korea
Ministry of Health & Welfare, Korea
Korean Association for the Study of Intestinal Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* All asymptomatic colonoscopic examinees
Exclusion criteria
* Familial history of hereditary colorectal cancer * History of colorectal cancer * Patients had received colonoscopy examination before * Familial or past history of FAP(familiar adenomatous polyposis) * Colonic polyposis syndrome * Prior colonic resection of any part of the colon * Allergy to indigo carmine * Inflammatory bowel disease * Pregnancy * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | 7 days is needed to confirm the pathologic examination. | The proportion of subjects with at least one adenoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proximal serrated polyp detection rate | 7 days is needed to confirm the pathologic examination. | Proportion of subjects with at least one proximal serrated polyp/adenoma |
| Advanced adenoma detection rate | 7 days is needed to confirm the pathologic examination. | Proportion of subjects with at least one advanced adenoma |
| Proximal adenoma detection rate | 7 days is needed to confirm the pathologic examination. | Proportion of subjects with at least one proximal colon adenoma |
| Cancer detection rate | 7 days is needed to confirm the pathologic examination. | Proportion of subjects with at least one cancer |
| Surveillance | 7 - 14 days | Surveillance interval recommendations for both groups were classified based on adenoma detection |
| Serrated adenoma detection rate | 7 days is needed to confirm the pathologic examination. | Proportion of subjects with at least one serrated adenoma |
Countries
South Korea
Outcome results
None listed