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Completed

NCT Number: NCT01112280

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

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.

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Key information

Conditions

Colorectal Neoplasm Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hallym University Medical Center, Anyang, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cap-assisted chromoendoscopy

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 .

Primary outcomes

  1. Adenoma detection rate

    Time frame: 7 days is needed to confirm the pathologic examination.

    The proportion of subjects with at least one adenoma

Secondary outcomes

  1. Proximal adenoma detection rate

    Time frame: 7 days is needed to confirm the pathologic examination.

    Proportion of subjects with at least one proximal colon adenoma

  2. Proximal serrated polyp detection rate

    Time frame: 7 days is needed to confirm the pathologic examination.

    Proportion of subjects with at least one proximal serrated polyp/adenoma

  3. Advanced adenoma detection rate

    Time frame: 7 days is needed to confirm the pathologic examination.

    Proportion of subjects with at least one advanced adenoma

  4. Serrated adenoma detection rate

    Time frame: 7 days is needed to confirm the pathologic examination.

    Proportion of subjects with at least one serrated adenoma

  5. Cancer detection rate

    Time frame: 7 days is needed to confirm the pathologic examination.

    Proportion of subjects with at least one cancer

  6. Surveillance

    Time frame: 7 - 14 days

    Surveillance interval recommendations for both groups were classified based on adenoma detection

Sponsors and collaborators

Lead sponsor

Korean Association for the Study of Intestinal Diseases

Other

Collaborators

  • Ministry of Health & Welfare, Korea
  • National Cancer Center, Korea

Registry information

Official study title

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

Acronym: CapACE

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 28, 2010
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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