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

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ClinicalTrials.gov Identifier: NCT01112280
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : December 13, 2018
Sponsor:
Collaborators:
National Cancer Center, Korea
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Hyun-Soo Kim, Korean Association for the Study of Intestinal Diseases

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasm Device: cap-assisted chromoendoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1905 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Controlled Trial of Cap-Assisted ChromoEndoscopy(CapACE) Versus Conventional Colonoscopy(CC) for the Detection of Colorectal Neoplasia
Actual Study Start Date : April 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cap-assisted chromoendoscopy
To the tip of the colonoscope, transparent cap is fitted and applied. In addition, panchromoendoscopy using indigocarmine solution is preformed in this group.
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, 0.09% indigocarmine was administered via irrigation cap .

No Intervention: Standard colonoscopy
Neither transparent cap nor chromoendoscopy is applied in this group and standard colonoscopy is performed.



Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: 7 days is needed to confirm the pathologic examination. ]
    The proportion of subjects with at least one adenoma


Secondary Outcome Measures :
  1. Proximal adenoma detection rate [ Time Frame: 7 days is needed to confirm the pathologic examination. ]
    Proportion of subjects with at least one proximal colon adenoma

  2. Proximal serrated polyp detection rate [ Time Frame: 7 days is needed to confirm the pathologic examination. ]
    Proportion of subjects with at least one proximal serrated polyp/adenoma

  3. Advanced adenoma detection rate [ Time Frame: 7 days is needed to confirm the pathologic examination. ]
    Proportion of subjects with at least one advanced adenoma

  4. Serrated adenoma detection rate [ Time Frame: 7 days is needed to confirm the pathologic examination. ]
    Proportion of subjects with at least one serrated adenoma

  5. Cancer detection rate [ Time Frame: 7 days is needed to confirm the pathologic examination. ]
    Proportion of subjects with at least one cancer

  6. Surveillance [ Time Frame: 7 - 14 days ]
    Surveillance interval recommendations for both groups were classified based on adenoma detection



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112280


Locations
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Korea, Republic of
Hallym University Medical Center
Anyang, Korea, Republic of
Kosin University College of Medicine
Busan, Korea, Republic of
Dankuk University college of medicine hospital
Cheonan, Korea, Republic of
National Cancer Center Hospital, National Cancer Center
Goyang, Korea, Republic of
Hanyang University Guri Hospital, Hanyang University College of Medicine
Guri-si, Korea, Republic of
Catholic university St. Mari's hospital
Incheon, Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Korea, Republic of
Ewha Mokdong hospital
Seoul, Korea, Republic of
Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine
Seoul, Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Korea, Republic of
Sunchunhyang University hospital
Seoul, Korea, Republic of
Sungkyunkwan University Kangbuk Samsung hospital
Seoul, Korea, Republic of
Yonsei University College of Medicine
Seoul, Korea, Republic of
Yonsei Uiniversity Wonju College of Medicine
Wonju, Korea, Republic of
Sponsors and Collaborators
Korean Association for the Study of Intestinal Diseases
National Cancer Center, Korea
Ministry of Health & Welfare, Korea
Investigators
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Principal Investigator: Hyun Soo Kim Korean Association for the Study of Intestinal Diseases

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Responsible Party: Hyun-Soo Kim, Professor, Korean Association for the Study of Intestinal Diseases
ClinicalTrials.gov Identifier: NCT01112280     History of Changes
Other Study ID Numbers: KASID polyp-01
MHWFA A092230 ( Other Grant/Funding Number: Ministry of Health, Welfare & Family Affairs, Korea )
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hyun-Soo Kim, Korean Association for the Study of Intestinal Diseases:
Colorectal neoplasm
Colonoscopy
chromoendoscopy
cap-assisted colonoscopy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases