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

NCT ID: NCT01112280

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1905 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-06-30

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.

Conditions

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Colorectal Neoplasm

Keywords

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Colorectal neoplasm Colonoscopy chromoendoscopy cap-assisted colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

cap-assisted chromoendoscopy

Intervention Type DEVICE

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 .

Standard colonoscopy

Neither transparent cap nor chromoendoscopy is applied in this group and standard colonoscopy is performed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 .

Intervention Type DEVICE

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role collaborator

Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

Korean Association for the Study of Intestinal Diseases

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun Soo Kim

Role: PRINCIPAL_INVESTIGATOR

Korean Association for the Study of Intestinal Diseases

Locations

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Hallym University Medical Center

Anyang, , South Korea

Site Status

Kosin University College of Medicine

Busan, , South Korea

Site Status

Dankuk University college of medicine hospital

Cheonan, , South Korea

Site Status

National Cancer Center Hospital, National Cancer Center

Goyang, , South Korea

Site Status

Hanyang University Guri Hospital, Hanyang University College of Medicine

Guri-si, , South Korea

Site Status

Catholic university St. Mari's hospital

Incheon, , South Korea

Site Status

Asan Medical Center, University of Ulsan College of Medicine

Seoul, , South Korea

Site Status

Ewha Mokdong hospital

Seoul, , South Korea

Site Status

Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine

Seoul, , South Korea

Site Status

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, , South Korea

Site Status

Sunchunhyang University hospital

Seoul, , South Korea

Site Status

Sungkyunkwan University Kangbuk Samsung hospital

Seoul, , South Korea

Site Status

Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Yonsei Uiniversity Wonju College of Medicine

Wŏnju, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 31972618 (View on PubMed)

Other Identifiers

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MHWFA A092230

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KASID polyp-01

Identifier Type: -

Identifier Source: org_study_id