Efficacy of Cap-assisted Chromoendoscopy as a Screening Test for Colorectal Neoplasm Using Web-based Research Network (CapACE)

This study is currently recruiting participants.
Verified June 2010 by Korean Association for the Study of Intestinal Diseases
Sponsor:
Collaborators:
National Cancer Center, Korea
Ministry of Health & Welfare, Korea
Information provided by:
Korean Association for the Study of Intestinal Diseases
ClinicalTrials.gov Identifier:
NCT01112280
First received: April 26, 2010
Last updated: June 27, 2010
Last verified: June 2010
  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

Resource links provided by NLM:


Further study details as provided by Korean Association for the Study of Intestinal Diseases:

Primary Outcome Measures:
  • Detection rate of colorectal neoplasia [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    7 days is needed to confirm the pathologic examination.


Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112280

Contacts
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

Locations
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         
Sponsors and Collaborators
Korean Association for the Study of Intestinal Diseases
National Cancer Center, Korea
Ministry of Health & Welfare, Korea
Investigators
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 April 16, 2014