Colonic NeoplasmNCT01725321
Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps
An observational study of Colonic Neoplasm, run by The University of Hong Kong at 1 site in China.
Trial summary
Although colonoscopy is considered the gold standard for diagnosis of colonic polyps, the missed rate for colonic adenoma ranged from 15-32%. In particular, missed colonic polyps in the right side colon have been suggested to be the cause for interval cancer that developed after a prior negative colonoscopy. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasm
- What is being tested?
- Narrow band imaging
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Oct 2013
- Phase
- Observational
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled to have colonoscopy for screening, surveillance or symptoms
Who may be able to join
- All patients scheduled to have colonoscopy
Who cannot join
- History of Crohn's or ulcerative colitis
- Surveillance for known polyposis syndrome (FAP or HNPCC)
- Previous colonic resection (except appendectomy)
- Refused consent
- Deranged coagulation profile that preclude polypectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colonoscopy With Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps
Although colonoscopy is considered the gold standard for diagnosis of colonic polyps, the missed rate for colonic adenoma ranged from 15-32%. In particular, missed colonic polyps in the right side colon have been suggested to be the cause for interval cancer that developed after a prior negative colonoscopy.
Different endoscopic image enhanced modules like the narrow band imaging (NBI) have been developed to improve colonic polyp detection. However, it remains controversial whether the previous version of NBI helps to improve colonic polyp detection. The new generation colonoscope is equipped with high definition and improved narrow band imaging (NBI) which gives at least twice the viewable distance and contrast. The images obtained are far brighter with better resolution than the previous version. It however remains to be determined whether this enhanced imaging technique could help to improve colonic polyps detection.
Read more
Hypothesis:
The new generation NBI increases the detection rate of proximal serrated polyps and reduces the missed rate of all colorectal polyps.
Aims:
- To determine whether the new generation NBI improve the detection rate of proximal serrated polyps.
- To determine whether the new generation NBI improve the detection rate of all colorectal adenoma and polyps.
- To determine whether the new generation NBI reduce the miss rate of colorectal adenoma and polyps.
Read the detailed description
Design:
Prospective randomized trial
Inclusion:
- All patients scheduled to have screening or scheduled colonoscopy
Exclusion:
- History of Crohn's or ulcerative colitis
- Surveillance for known polyposis syndrome (FAP or HNPCC)
- Previous colonic resection (except appendectomy)
- Refused consent
- Deranged coagulation profile that preclude polypectomy
- Conditions
- Colonic Neoplasm
- Being tested
- Narrow band imaging
- Keywords
- Colonoscopy, colonic adenoma, serrated polyps
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow band imagingOther
Colonoscopy with new narrow band imaging
| Study group | Role | What they receive |
|---|---|---|
| Narrow band imaging | Colonoscopy with new narrow band imaging Receives: Other: Narrow band imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of proximal serrated polyp
No. of patients with proximal serrated polyps
Measured: During colonoscopy
Secondary outcomes (1)
Missed rate for proximal serrated polyps
Missing rate for proximal serrated polyps
Measured: During colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEUNG Wai Keung, The University of Hong Kong
- Investigators
- Wai Keung Leung, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725321
- Sponsor's protocol ID
- NBI_1
- Status last verified
- May 2015
- First submitted
- 8 Nov 2012
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopy With Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps
- ClinicalTrials.gov ID
- NCT01725321
- Acronym / sponsor ID
- NBI_1
- Conditions
- Colonic Neoplasm
- Keywords
- Colonoscopy, colonic adenoma, serrated polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 Nov 2012 (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.
Although colonoscopy is considered the gold standard for diagnosis of colonic polyps, the missed rate for colonic adenoma ranged from 15-32%. In particular, missed colonic polyps in the right side colon have been suggested to be the cause for interval cancer that developed after a prior negative colonoscopy.
Different endoscopic image enhanced modules like the narrow band imaging (NBI) have been developed to improve colonic polyp detection. However, it remains controversial whether the previous version of NBI helps to improve colonic polyp detection. The new generation colonoscope is equipped with high definition and improved narrow band imaging (NBI) which gives at least twice the viewable distance and contrast. The images obtained are far brighter with better resolution than the previous version. It however remains to be determined whether this enhanced imaging technique could help to improve colonic polyps detection.
Hypothesis:
The new generation NBI increases the detection rate of proximal serrated polyps and reduces the missed rate of all colorectal polyps.
Aims:
- To determine whether the new generation NBI improve the detection rate of proximal serrated polyps.
- To determine whether the new generation NBI improve the detection rate of all colorectal adenoma and polyps.
- To determine whether the new generation NBI reduce the miss rate of colorectal adenoma and polyps.
Detailed description
Design:
Prospective randomized trial
Inclusion:
- All patients scheduled to have screening or scheduled colonoscopy
Exclusion:
- History of Crohn's or ulcerative colitis
- Surveillance for known polyposis syndrome (FAP or HNPCC)
- Previous colonic resection (except appendectomy)
- Refused consent
- Deranged coagulation profile that preclude polypectomy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Narrow band imaging | – | Other: Narrow band imagingColonoscopy with new narrow band imaging |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to have colonoscopy for screening, surveillance or symptoms
Key inclusion criteria (1 listed)
- All patients scheduled to have colonoscopy
Key exclusion criteria (5 listed)
- History of Crohn's or ulcerative colitis
- Surveillance for known polyposis syndrome (FAP or HNPCC)
- Previous colonic resection (except appendectomy)
- Refused consent
- Deranged coagulation profile that preclude polypectomy
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 |
|---|---|---|
| Narrow band imagingColonoscopy with new narrow band imaging | Other | Narrow band imaging |
Primary outcome
Detection rate of proximal serrated polyp
Time frame: During colonoscopy
No. of patients with proximal serrated polyps
1 secondary outcome
Missed rate for proximal serrated polyps
Time frame: During colonoscopy
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 29 May 2015.
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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.
Wai Keung Leung, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Neoplasm, run by The University of Hong Kong at 1 site in China.
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 5 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Detection rate of proximal serrated polyp (time frame: During colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2015.