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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Neoplasm

Intervention / Treatment
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* Device: cap-assisted chromoendoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cap-assisted chromoendoscopy<br>To the tip of the colonoscope, transparent cap is fitted and applied. In addition, panchromoendoscopy using indigocarmine solution is preformed in this group. | Device: cap-assisted chromoendoscopy<br>* 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 .<br>|
| No Intervention: Standard colonoscopy<br>Neither transparent cap nor chromoendoscopy is applied in this group and standard colonoscopy is performed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | The proportion of subjects with at least one adenoma | 7 days is needed to confirm the pathologic examination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal adenoma detection rate | Proportion of subjects with at least one proximal colon adenoma | 7 days is needed to confirm the pathologic examination. | 
| 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. | 
| Advanced adenoma detection rate | Proportion of subjects with at least one advanced adenoma | 7 days is needed to confirm the pathologic examination. | 
| Serrated adenoma detection rate | Proportion of subjects with at least one serrated adenoma | 7 days is needed to confirm the pathologic examination. | 
| Cancer detection rate | Proportion of subjects with at least one cancer | 7 days is needed to confirm the pathologic examination. | 
| Surveillance | Surveillance interval recommendations for both groups were classified based on adenoma detection | 7 - 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal neoplasm, Colonoscopy, chromoendoscopy, cap-assisted colonoscopy