Efficacy of Cap-assisted Chromoendoscopy as a Screening Test for Colorectal Neoplasm Using Web-based Research Network
CapACE
Prospective Randomized Controlled Trial of Cap-Assisted ChromoEndoscopy(CapACE) Versus Conventional Colonoscopy(CC) for the Detection of Colorectal Neoplasia
2 other identifiers
interventional
1,905
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 26, 2010
CompletedFirst Posted
Study publicly available on registry
April 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedDecember 13, 2018
December 1, 2018
1.9 years
April 26, 2010
December 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma detection rate
The proportion of subjects with at least one adenoma
7 days is needed to confirm the pathologic examination.
Secondary Outcomes (6)
Proximal adenoma detection rate
7 days is needed to confirm the pathologic examination.
Proximal serrated polyp detection rate
7 days is needed to confirm the pathologic examination.
Advanced adenoma detection rate
7 days is needed to confirm the pathologic examination.
Serrated adenoma detection rate
7 days is needed to confirm the pathologic examination.
Cancer detection rate
7 days is needed to confirm the pathologic examination.
- +1 more secondary outcomes
Study Arms (2)
cap-assisted chromoendoscopy
EXPERIMENTALTo the tip of the colonoscope, transparent cap is fitted and applied. In addition, panchromoendoscopy using indigocarmine solution is preformed in this group.
Standard colonoscopy
NO INTERVENTIONNeither transparent cap nor chromoendoscopy is applied in this group and standard colonoscopy is performed.
Interventions
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 .
Eligibility Criteria
You may qualify if:
- All asymptomatic colonoscopic examinees
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Hallym University Medical Center
Anyang, South Korea
Kosin University College of Medicine
Busan, South Korea
Dankuk University college of medicine hospital
Cheonan, South Korea
National Cancer Center Hospital, National Cancer Center
Goyang, South Korea
Hanyang University Guri Hospital, Hanyang University College of Medicine
Guri-si, South Korea
Catholic university St. Mari's hospital
Incheon, South Korea
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
Ewha Mokdong hospital
Seoul, South Korea
Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine
Seoul, South Korea
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
Sunchunhyang University hospital
Seoul, South Korea
Sungkyunkwan University Kangbuk Samsung hospital
Seoul, South Korea
Yonsei University College of Medicine
Seoul, South Korea
Yonsei Uiniversity Wonju College of Medicine
Wŏnju, South Korea
Related Publications (1)
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.
PMID: 31972618DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyun Soo Kim
Korean Association for the Study of Intestinal Diseases
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 26, 2010
First Posted
April 28, 2010
Study Start
April 1, 2010
Primary Completion
March 1, 2012
Study Completion
June 1, 2012
Last Updated
December 13, 2018
Record last verified: 2018-12