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

Primary Purpose

Colorectal Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cap-assisted chromoendoscopy
Sponsored by
Korean Association for the Study of Intestinal Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasm focused on measuring Colorectal neoplasm, Colonoscopy, chromoendoscopy, cap-assisted colonoscopy

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hallym University Medical Center
  • Kosin University College of Medicine
  • Dankuk University college of medicine hospital
  • National Cancer Center Hospital, National Cancer Center
  • Hanyang University Guri Hospital, Hanyang University College of Medicine
  • Catholic university St. Mari's hospital
  • Asan Medical Center, University of Ulsan College of Medicine
  • Ewha Mokdong hospital
  • Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine
  • Samsung Medical Center, Sungkyunkwan University School of Medicine
  • Sunchunhyang University hospital
  • Sungkyunkwan University Kangbuk Samsung hospital
  • Yonsei University College of Medicine
  • Yonsei Uiniversity Wonju College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cap-assisted chromoendoscopy

Standard colonoscopy

Arm Description

To the tip of the colonoscope, transparent cap is fitted and applied. In addition, panchromoendoscopy using indigocarmine solution is preformed in this group.

Neither transparent cap nor chromoendoscopy is applied in this group and standard colonoscopy is performed.

Outcomes

Primary Outcome Measures

Adenoma detection rate
The proportion of subjects with at least one adenoma

Secondary Outcome Measures

Proximal adenoma detection rate
Proportion of subjects with at least one proximal colon adenoma
Proximal serrated polyp detection rate
Proportion of subjects with at least one proximal serrated polyp/adenoma
Advanced adenoma detection rate
Proportion of subjects with at least one advanced adenoma
Serrated adenoma detection rate
Proportion of subjects with at least one serrated adenoma
Cancer detection rate
Proportion of subjects with at least one cancer
Surveillance
Surveillance interval recommendations for both groups were classified based on adenoma detection

Full Information

First Posted
April 26, 2010
Last Updated
December 11, 2018
Sponsor
Korean Association for the Study of Intestinal Diseases
Collaborators
National Cancer Center, Korea, Ministry of Health & Welfare, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01112280
Brief Title
Efficacy of Cap-assisted Chromoendoscopy as a Screening Test for Colorectal Neoplasm Using Web-based Research Network
Acronym
CapACE
Official Title
Prospective Randomized Controlled Trial of Cap-Assisted ChromoEndoscopy(CapACE) Versus Conventional Colonoscopy(CC) for the Detection of Colorectal Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korean Association for the Study of Intestinal Diseases
Collaborators
National Cancer Center, Korea, Ministry of Health & Welfare, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasm
Keywords
Colorectal neoplasm, Colonoscopy, chromoendoscopy, cap-assisted colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1905 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cap-assisted chromoendoscopy
Arm Type
Experimental
Arm Description
To the tip of the colonoscope, transparent cap is fitted and applied. In addition, panchromoendoscopy using indigocarmine solution is preformed in this group.
Arm Title
Standard colonoscopy
Arm Type
No Intervention
Arm Description
Neither transparent cap nor chromoendoscopy is applied in this group and standard colonoscopy is performed.
Intervention Type
Device
Intervention Name(s)
cap-assisted chromoendoscopy
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
The proportion of subjects with at least one adenoma
Time Frame
7 days is needed to confirm the pathologic examination.
Secondary Outcome Measure Information:
Title
Proximal adenoma detection rate
Description
Proportion of subjects with at least one proximal colon adenoma
Time Frame
7 days is needed to confirm the pathologic examination.
Title
Proximal serrated polyp detection rate
Description
Proportion of subjects with at least one proximal serrated polyp/adenoma
Time Frame
7 days is needed to confirm the pathologic examination.
Title
Advanced adenoma detection rate
Description
Proportion of subjects with at least one advanced adenoma
Time Frame
7 days is needed to confirm the pathologic examination.
Title
Serrated adenoma detection rate
Description
Proportion of subjects with at least one serrated adenoma
Time Frame
7 days is needed to confirm the pathologic examination.
Title
Cancer detection rate
Description
Proportion of subjects with at least one cancer
Time Frame
7 days is needed to confirm the pathologic examination.
Title
Surveillance
Description
Surveillance interval recommendations for both groups were classified based on adenoma detection
Time Frame
7 - 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Soo Kim
Organizational Affiliation
Korean Association for the Study of Intestinal Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Medical Center
City
Anyang
Country
Korea, Republic of
Facility Name
Kosin University College of Medicine
City
Busan
Country
Korea, Republic of
Facility Name
Dankuk University college of medicine hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
National Cancer Center Hospital, National Cancer Center
City
Goyang
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital, Hanyang University College of Medicine
City
Guri-si
Country
Korea, Republic of
Facility Name
Catholic university St. Mari's hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Mokdong hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Sunchunhyang University hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Sungkyunkwan University Kangbuk Samsung hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei Uiniversity Wonju College of Medicine
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31972618
Citation
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.
Results Reference
derived

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

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