ColonoscopyNCT00908648
The Use of Narrow Band Imaging in Screening Colonoscopy
A study testing Narrow Band Imaging in people with Colonoscopy, run by Valduce Hospital.
Trial summary
Narrow band imaging (NBI) is an imaging technique that allows a better definition of capillary pattern and improves the contrast between adenomas and the surrounding mucosa. Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the impact of NBI is being tested in several screening… Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Narrow Band Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-69 year-old asymptomatic subjects at average-risk of CRC
- positive FOBT participating in a national mass-screening program and referred for colonoscopy
Who cannot join
- ongoing anticoagulation therapy
- inadequate bowel cleansing
- incomplete colonoscopy
- refusing to participate
About this study
Official title: The Impact of Narrow Band Imaging in Screening Colonoscopy: a Randomized Controlled Trial.
Narrow band imaging (NBI) is an imaging technique that allows a better definition of capillary pattern and improves the contrast between adenomas and the surrounding mucosa. Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the impact of NBI is being tested in several screening scenarios. The investigators evaluated whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of screening colonoscopy improved adenoma detection.
- Conditions
- Colonoscopy
- Being tested
- Narrow Band Imaging
- Keywords
- screening colonoscopy, narrow band imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow Band ImagingProcedure or surgery
Narrow Band Imaging
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | standard white light |
| 2 | Experimental | Narrow Band Imaging Receives: Procedure: Narrow Band Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection
Detection of adenoma, defined as the number of patients with > 1 adenoma, under White Light or NBI visualization
Measured: duration of colonoscopy procedure
Secondary outcomes (1)
Detection of Flat and/or Depressed Adenomas
number of patients with at least 1 flat and/or depressed adenoma
Measured: duration of colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vittorio Terruzzi, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908648
- Sponsor's protocol ID
- NBI-01
- Status last verified
- Mar 2021
- First submitted
- 22 Jan 2009
- Last updated
- 26 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Machida H, Sano Y, Hamamoto Y, Muto M, Kozu T, Tajiri H, Yoshida S. Narrow-band imaging in the diagnosis of colorectal mucosal lesions: a pilot study. Endoscopy. 2004 Dec;36(12):1094-8. doi: 10.1055/s-2004-826040.
PubMed 15578301Chiu HM, Chang CY, Chen CC, Lee YC, Wu MS, Lin JT, Shun CT, Wang HP. A prospective comparative study of narrow-band imaging, chromoendoscopy, and conventional colonoscopy in the diagnosis of colorectal neoplasia. Gut. 2007 Mar;56(3):373-9. doi: 10.1136/gut.2006.099614. Epub 2006 Sep 27.
PubMed 17005766
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Narrow Band Imaging in Screening Colonoscopy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00908648
- Acronym / sponsor ID
- NBI-01
- Conditions
- Colonoscopy
- Keywords
- screening colonoscopy, narrow band imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Posted 27 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Narrow band imaging (NBI) is an imaging technique that allows a better definition of capillary pattern and improves the contrast between adenomas and the surrounding mucosa. Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the impact of NBI is being tested in several screening scenarios. The investigators evaluated whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of screening colonoscopy improved adenoma detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –standard white light |
| 2 | Experimental | Procedure: Narrow Band ImagingNarrow Band Imaging |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50-69 year-old asymptomatic subjects at average-risk of CRC
- positive FOBT participating in a national mass-screening program and referred for colonoscopy
Key exclusion criteria (4 listed)
- ongoing anticoagulation therapy
- inadequate bowel cleansing
- incomplete colonoscopy
- refusing to participate
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 ImagingNarrow Band Imaging | Procedure or surgery | 2 |
Primary outcome
Adenoma Detection
Time frame: duration of colonoscopy procedure
Detection of adenoma, defined as the number of patients with > 1 adenoma, under White Light or NBI visualization
1 secondary outcome
Detection of Flat and/or Depressed Adenomas
Time frame: duration of colonoscopy procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15578301Machida H, Sano Y, Hamamoto Y, Muto M, Kozu T, Tajiri H, Yoshida S. Narrow-band imaging in the diagnosis of colorectal mucosal lesions: a pilot study. Endoscopy. 2004 Dec;36(12):1094-8. doi: 10.1055/s-2004-826040.
- Background: PubMed 17005766Chiu HM, Chang CY, Chen CC, Lee YC, Wu MS, Lin JT, Shun CT, Wang HP. A prospective comparative study of narrow-band imaging, chromoendoscopy, and conventional colonoscopy in the diagnosis of colorectal neoplasia. Gut. 2007 Mar;56(3):373-9. doi: 10.1136/gut.2006.099614. Epub 2006 Sep 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow Band Imaging in people with Colonoscopy, run by Valduce Hospital.
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 2 inclusion and 4 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 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 27 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: duration of colonoscopy procedure). 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 NCT00908648, which also lists 2 linked publications.
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 26 Apr 2021.