Efficacy of Cap-assisted Chromoendoscopy as a Screening Test for Colorectal Neoplasm Using Web-based Research Network
- Conditions
- Colorectal Neoplasm
- Interventions
- Device: cap-assisted chromoendoscopy
- Registration Number
- NCT01112280
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1905
- All asymptomatic colonoscopic examinees
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cap-assisted chromoendoscopy 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.
- Primary Outcome Measures
Name Time Method Adenoma detection rate 7 days is needed to confirm the pathologic examination. The proportion of subjects with at least one adenoma
- Secondary Outcome Measures
Name Time Method Advanced adenoma detection rate 7 days is needed to confirm the pathologic examination. Proportion of subjects with at least one advanced adenoma
Cancer detection rate 7 days is needed to confirm the pathologic examination. Proportion of subjects with at least one cancer
Surveillance 7 - 14 days Surveillance interval recommendations for both groups were classified based on adenoma detection
Proximal adenoma detection rate 7 days is needed to confirm the pathologic examination. Proportion of subjects with at least one proximal colon adenoma
Serrated adenoma detection rate 7 days is needed to confirm the pathologic examination. Proportion of subjects with at least one serrated adenoma
Proximal serrated polyp detection rate 7 days is needed to confirm the pathologic examination. Proportion of subjects with at least one proximal serrated polyp/adenoma
Trial Locations
- Locations (14)
Hanyang University Guri Hospital, Hanyang University College of Medicine
🇰🇷Guri-si, Korea, Republic of
Hallym University Medical Center
🇰🇷Anyang, Korea, Republic of
Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine
🇰🇷Seoul, Korea, Republic of
Dankuk University college of medicine hospital
🇰🇷Cheonan, Korea, Republic of
Catholic university St. Mari's hospital
🇰🇷Incheon, Korea, Republic of
Ewha Mokdong hospital
🇰🇷Seoul, Korea, Republic of
National Cancer Center Hospital, National Cancer Center
🇰🇷Goyang, Korea, Republic of
Yonsei Uiniversity Wonju College of Medicine
🇰🇷Wonju, Korea, Republic of
Kosin University College of Medicine
🇰🇷Busan, Korea, Republic of
Sunchunhyang University hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine
🇰🇷Seoul, Korea, Republic of
Sungkyunkwan University Kangbuk Samsung hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of