Colorectal NeoplasmCapACENCT01112280
Efficacy of Cap-assisted Chromoendoscopy as a Screening Test for Colorectal Neoplasm Using Web-based Research Network
A study testing cap-assisted chromoendoscopy in people with Colorectal Neoplasm, run by Korean Association for the Study of Intestinal Diseases at 14 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- cap-assisted chromoendoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,905 participants
- Where
- 14 sitesSouth Korea
- Study dates
- Apr 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All asymptomatic colonoscopic examinees
Who cannot join
- 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
Show all 10Show fewer
- Allergy to indigo carmine
- Inflammatory bowel disease
- Pregnancy
- Inability to provide informed consent
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Hallym University Medical Center
Anyang
Kosin University College of Medicine
Busan
Dankuk University college of medicine hospital
Cheonan
National Cancer Center Hospital, National Cancer Center
Goyang
Hanyang University Guri Hospital, Hanyang University College of Medicine
Guri-si
Catholic university St. Mari's hospital
Incheon
Asan Medical Center, University of Ulsan College of Medicine
Seoul
Ewha Mokdong hospital
Seoul
Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine
Seoul
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul
Sunchunhyang University hospital
Seoul
Sungkyunkwan University Kangbuk Samsung hospital
Seoul
Yonsei University College of Medicine
Seoul
Yonsei Uiniversity Wonju College of Medicine
Wŏnju
About this study
Official title: Prospective Randomized Controlled Trial of Cap-Assisted ChromoEndoscopy(CapACE) Versus Conventional Colonoscopy(CC) for the Detection of Colorectal Neoplasia
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.
Read the 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.
- Conditions
- Colorectal Neoplasm
- Being tested
- cap-assisted chromoendoscopy
- Keywords
- Colorectal neoplasm, Colonoscopy, chromoendoscopy, cap-assisted colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cap-assisted chromoendoscopyDevice
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 .
| Study group | Role | What they receive |
|---|---|---|
| cap-assisted chromoendoscopy | Experimental | To the tip of the colonoscope, transparent cap is fitted and applied. In addition, panchromoendoscopy using indigocarmine solution is preformed in this group. Receives: Device: cap-assisted chromoendoscopy |
| Standard colonoscopy | No intervention | Neither transparent cap nor chromoendoscopy is applied in this group and standard colonoscopy is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
The proportion of subjects with at least one adenoma
Measured: 7 days is needed to confirm the pathologic examination.
Secondary outcomes (6)
Proximal adenoma detection rate
Proportion of subjects with at least one proximal colon adenoma
Measured: 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
Measured: 7 days is needed to confirm the pathologic examination.
Advanced adenoma detection rate
Proportion of subjects with at least one advanced adenoma
Measured: 7 days is needed to confirm the pathologic examination.
Serrated adenoma detection rate
Proportion of subjects with at least one serrated adenoma
Measured: 7 days is needed to confirm the pathologic examination.
Cancer detection rate
Proportion of subjects with at least one cancer
Measured: 7 days is needed to confirm the pathologic examination.
Surveillance
Surveillance interval recommendations for both groups were classified based on adenoma detection
Measured: 7 - 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,905 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Association for the Study of Intestinal Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Center, Korea, Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Hyun-Soo Kim, Korean Association for the Study of Intestinal Diseases
- Investigators
- Hyun Soo Kim, Principal investigator, Korean Association for the Study of Intestinal Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112280
- Sponsor's protocol ID
- KASID polyp-01
- Other IDs
- MHWFA A092230
- Acronym
- CapACE
- Status last verified
- Dec 2018
- First submitted
- 26 Apr 2010
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 31972618
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Cap-Assisted ChromoEndoscopy(CapACE) Versus Conventional Colonoscopy(CC) for the Detection of Colorectal Neoplasia
- ClinicalTrials.gov ID
- NCT01112280
- Acronym / sponsor ID
- CapACE / KASID polyp-01
- Conditions
- Colorectal Neoplasm
- Keywords
- Colorectal neoplasm, Colonoscopy, chromoendoscopy, cap-assisted colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,905 participants (actual)
- Lead sponsor
- Korean Association for the Study of Intestinal DiseasesUniversity, hospital or other
- Collaborators
- National Cancer Center, Korea, Ministry of Health & Welfare, Korea
- Study start
- Apr 2010 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cap-assisted chromoendoscopy | Experimental | Device: cap-assisted chromoendoscopyTo the tip of the colonoscope, transparent cap is fitted and applied. In addition, panchromoendoscopy using indigocarmine solution is preformed in this group. |
| Standard colonoscopy | No intervention | –Neither transparent cap nor chromoendoscopy is applied in this group and standard colonoscopy is performed. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All asymptomatic colonoscopic examinees
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cap-assisted chromoendoscopyA 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 . | Device | cap-assisted chromoendoscopy |
Primary outcome
Adenoma detection rate
Time frame: 7 days is needed to confirm the pathologic examination.
The proportion of subjects with at least one adenoma
6 secondary outcomes
Proximal adenoma detection rate
Time frame: 7 days is needed to confirm the pathologic examination.
Proximal serrated polyp detection rate
Time frame: 7 days is needed to confirm the pathologic examination.
Advanced adenoma detection rate
Time frame: 7 days is needed to confirm the pathologic examination.
Serrated adenoma detection rate
Time frame: 7 days is needed to confirm the pathologic examination.
Cancer detection rate
Time frame: 7 days is needed to confirm the pathologic examination.
Surveillance
Time frame: 7 - 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Derived from this study: PubMed 31972618Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Soo Kim principal investigator
Korean Association for the Study of Intestinal Diseases
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cap-assisted chromoendoscopy in people with Colorectal Neoplasm, run by Korean Association for the Study of Intestinal Diseases at 14 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 7 days is needed to confirm the pathologic examination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.