Efficacy of Cap-assisted Chromoendoscopy as a Screening Test for Colorectal Neoplasm Using Web-based Research Network (CapACE)
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Purpose
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. The investigators plan to conduct a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for colorectal polyp, and the impact on 3-year polyp recurrence rate. This study will be performed using web-based research network, e-VELOS in Korea.
| Condition | Intervention |
|---|---|
|
Colorectal Neoplasm |
Device: cap-assisted chromoendoscopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Prospective Randomized Controlled Trial of Cap-Assisted ChromoEndoscopy(CapACE) Versus Conventional Colonoscopy(CC) for the Detection and 3-year Recurrence Rate of Colorectal Neoplasia |
- Detection rate of colorectal neoplasia [ Time Frame: 7 days ] [ Designated as safety issue: No ]7 days is needed to confirm the pathologic examination.
- 3-year recurrence rate of colorectal neoplasia [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- Risk of colorectal adenoma according to the presence of hyperplastic polyp in distal rectum and 3 year recurrence rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Detection and 3-year recurrence rate of hyperplastic polyp and serrated adenoma in asymptomatic people. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- The association of gallbladder disease of stone or tumor and colorectal polyp [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- Detection rate of colorectal polyp according to Quality indices of colonoscopy [ Time Frame: 7 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: cap-assisted chromoendoscopy |
Device: cap-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, 0.15-0.2% indigocarmine was administered via irrigation cap . |
| No Intervention: Conventional colonoscopy |
Device: cap-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, 0.15-0.2% indigocarmine was administered via irrigation cap . |
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- All asymptomatic colonoscopic examinees
Exclusion Criteria:
- Familial history of hereditary colorectal cancer
- History of colorectal neoplasm
- Patients had received colonoscopy examination before
- Familial or past history of FAP(familiar adenomatous polyposis)
- Prior colonic resection
- Familial history of inflammatory bowel disease(IBD)
- Inflammatory bowel disease
Contacts and Locations| Contact: Hyun Soo Kim, M.D., Ph.D. | 82-33-741-1224 | hyskim@yonsei.ac.kr |
| Contact: Seong-Eun Kim | 82-2-2650-2859 | kimse@ewha.ac.kr |
| Korea, Republic of | |
| Dankuk University college of medicine hospital | Recruiting |
| Cheonan, Korea, Republic of | |
| Contact: Jeong Eun Shin, MD, PhD dreun1028@yahoo.co.kr | |
| Principal Investigator: Jeong Eun Shin | |
| Catholic university St. Mari's hospital | Recruiting |
| Incheon, Korea, Republic of | |
| Contact: Hwang Choi, MD, PhD | |
| Principal Investigator: Hwang Choi | |
| Sungkyunkwan University Kangbuk Samsung hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Dong Il Park diksmc.park@samsung.com | |
| Principal Investigator: Dong Il Park, MD, PhD | |
| Sunchunhyang University hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Jin Oh Kim ddcnt@hosp.sch.ac.kr | |
| Principal Investigator: Jin Oh Kim, MD, PhD | |
| Ewha Mokdong hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Seong-Eun Kim | |
| Principal Investigator: Seong-Eun Kim, MD, PhD | |
| Yonsei Uiniversity Wonju College of Medicine | Recruiting |
| Wonju, Korea, Republic of | |
| Contact: Hyun Soo Kim, MD, PhD hyskim@yonsei.ac.kr | |
| Principal Investigator: Hyun Soo Kim, MD, PhD | |
| Sub-Investigator: Chan Sik Won, MD | |
| Principal Investigator: | Hyun Soo Kim | Korean Association for the Study of Intestinal Diseases |
More Information
No publications provided
| Responsible Party: | Hyun Soo Kim / Chief of KASID polyp research group, KASID(Korean Associatio for the Study of the Intestinal Diseases) |
| ClinicalTrials.gov Identifier: | NCT01112280 History of Changes |
| Other Study ID Numbers: | KASID polyp-01, MHWFA A092230 |
| Study First Received: | April 26, 2010 |
| Last Updated: | June 27, 2010 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Korean Association for the Study of Intestinal Diseases:
|
Colorectal neoplasm Colonoscopy chromoendoscopy cap-assisted colonoscopy |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013