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

Colorectal Neoplasm Clinical Trial

— CapACE  

Official title:

Prospective Randomized Controlled Trial of Cap-Assisted ChromoEndoscopy(CapACE) Versus Conventional Colonoscopy(CC) for the Detection of Colorectal Neoplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112280
• Other study ID #: KASID polyp-01
• Secondary ID: MHWFA A092230
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: June 2012

Study information

• Verified date: December 2018
• Source: Korean Association for the Study of Intestinal Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1905
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasm
• Colorectal Neoplasms
• Neoplasms

Intervention

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 .

Locations

Country	Name	City	State
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

Sponsors (3)

Lead Sponsor	Collaborator
Korean Association for the Study of Intestinal Diseases	Ministry of Health & Welfare, Korea, National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	The proportion of subjects with at least one adenoma	7 days is needed to confirm the pathologic examination.
Secondary	Proximal adenoma detection rate	Proportion of subjects with at least one proximal colon adenoma	7 days is needed to confirm the pathologic examination.
Secondary	Proximal serrated polyp detection rate	Proportion of subjects with at least one proximal serrated polyp/adenoma	7 days is needed to confirm the pathologic examination.
Secondary	Advanced adenoma detection rate	Proportion of subjects with at least one advanced adenoma	7 days is needed to confirm the pathologic examination.
Secondary	Serrated adenoma detection rate	Proportion of subjects with at least one serrated adenoma	7 days is needed to confirm the pathologic examination.
Secondary	Cancer detection rate	Proportion of subjects with at least one cancer	7 days is needed to confirm the pathologic examination.
Secondary	Surveillance	Surveillance interval recommendations for both groups were classified based on adenoma detection	7 - 14 days