Clinical trial NCT01112280: Efficacy of Cap-assisted Chromoendoscopy as a Screening Test for Colorectal Neoplasm Using Web-based Research Network
Official title: Prospective Randomized Controlled Trial of Cap-Assisted ChromoEndoscopy(CapACE) Versus Conventional Colonoscopy(CC) for the Detection of Colorectal Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasm
Keywords: Colorectal neoplasm
Colonoscopy
chromoendoscopy
cap-assisted colonoscopy
Lead sponsor: Korean Association for the Study of Intestinal Diseases
Sponsor class: OTHER
Collaborators: name: National Cancer Center, Korea
name: Ministry of Health & Welfare, Korea
First posted: 2010-04-28
Enrollment: 1905
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 7 days is needed to confirm the pathologic examination.
Secondary outcomes:
measure: Proximal adenoma detection rate
timeFrame: 7 days is needed to confirm the pathologic examination.
measure: Proximal serrated polyp detection rate
timeFrame: 7 days is needed to confirm the pathologic examination.
measure: Advanced adenoma detection rate
timeFrame: 7 days is needed to confirm the pathologic examination.
measure: Serrated adenoma detection rate
timeFrame: 7 days is needed to confirm the pathologic examination.
measure: Cancer detection rate
timeFrame: 7 days is needed to confirm the pathologic examination.
measure: Surveillance
timeFrame: 7 - 14 days
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
city: Busan
country: Korea, Republic of
facility: Kosin University College of Medicine
city: Cheonan
country: Korea, Republic of
facility: Dankuk University college of medicine hospital
city: Goyang
country: Korea, Republic of
facility: National Cancer Center Hospital, National Cancer Center
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital, Hanyang University College of Medicine
city: Incheon
country: Korea, Republic of
facility: Catholic university St. Mari's hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
city: Seoul
country: Korea, Republic of
facility: Ewha Mokdong hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Sunchunhyang University hospital
city: Seoul
country: Korea, Republic of
facility: Sungkyunkwan University Kangbuk Samsung hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
city: Wonju
country: Korea, Republic of
facility: Yonsei Uiniversity Wonju College of Medicine
Study officials:
affiliation: Korean Association for the Study of Intestinal Diseases
name: Hyun Soo Kim
role: PRINCIPAL_INVESTIGATOR
References:
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.