Narrow Band ImagingNCT03081975
Comparison of ADR Using NBI Versus HD White Light Colonoscopy in Screening and Surveillance Colonoscopies
A study testing HD white light or NBI in people with Narrow Band Imaging, run by Jena University Hospital at 1 site in Germany.
Trial summary
The aim of this study is to compare ADR using HD-NBI or HD-WLE during screening and surveillance colonoscopies. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Narrow Band Imaging
- What is being tested?
- HD white light or NBI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Dec 2017
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Screening colonoscopies
Who cannot join
- Insufficient bowel cleansing
- Age under 55years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Adenoma Detection Rate Using Narrow Band Imaging Versus HD White Light Colonoscopy in Screening and Surveillance Colonoscopies
The aim of this study is to compare ADR using HD-NBI or HD-WLE during screening and surveillance colonoscopies.
Read the detailed description
Background:
Despite recent advances in endoscopic technology adenoma miss rate still is up to 20% and contributes to the occurrence of interval cancers. Therefore, improved imaging modalities have been introduced to increase adenoma detection rate (ADR) during screening and surveillance colonoscopies. Recently, narrow band imaging (NBI; Exera II series, Olympus Corporation) was not significantly better than high definition white light colonoscopy (WLC) for the detection of patients with colorectal polyps, or colorectal adenomas1. However, Olympus' current Exera III series is characterized by better illumination of the bowel lumen and may be associated with a higher ADR than high definition WLC.
Methods:
Investigators performed a prospective evaluation in patients referred to the Department of Interdisciplinary Endoscopy at Jena University Hospital for screening or surveillance colonoscopy between January and November 2015 in daily clinical practice. Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal of the colonoscope (Exera III series, Olympus Corporation).
- Conditions
- Narrow Band Imaging
- Being tested
- HD white light or NBI
- Keywords
- adenoma detection rate, narrow band imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD white light or NBIDevice
Use of NBI or HD white light
| Study group | Role | What they receive |
|---|---|---|
| HD white light | Active comparator | Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal Receives: Device: HD white light or NBI |
| HD narrow band imaging | Active comparator | Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal Receives: Device: HD white light or NBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Adenoma detection rate
Measured: up to 60min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study startJan 2015
- Primary completionDec 2017
- Study completionDec 2017
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 Narrow Band ImagingStudies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Bürger, Jena University Hospital
- Investigators
- Carsten Schmidt, MD, Study director, University Clinic Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081975
- Sponsor's protocol ID
- NBI01
- Status last verified
- Mar 2018
- First submitted
- 4 Mar 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- Individual data sharing
- No
Publications
Burger M, Weber M, Petersen I, Stallmach A, Schmidt C. Adenoma detection rate using narrow-band imaging is inferior to high-definition white light colonoscopy in screening and surveillance colonoscopies in daily clinical care: A randomized controlled trial. Medicine (Baltimore). 2022 Aug 12;101(32):e29858. doi: 10.1097/MD.0000000000029858.
PubMed 35960070
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adenoma Detection Rate Using Narrow Band Imaging Versus HD White Light Colonoscopy in Screening and Surveillance Colonoscopies
- ClinicalTrials.gov ID
- NCT03081975
- Acronym / sponsor ID
- NBI01
- Conditions
- Narrow Band Imaging
- Keywords
- adenoma detection rate, narrow band imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Mar 2017 (actual)
- 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 aim of this study is to compare ADR using HD-NBI or HD-WLE during screening and surveillance colonoscopies.
Detailed description
Background:
Despite recent advances in endoscopic technology adenoma miss rate still is up to 20% and contributes to the occurrence of interval cancers. Therefore, improved imaging modalities have been introduced to increase adenoma detection rate (ADR) during screening and surveillance colonoscopies. Recently, narrow band imaging (NBI; Exera II series, Olympus Corporation) was not significantly better than high definition white light colonoscopy (WLC) for the detection of patients with colorectal polyps, or colorectal adenomas1. However, Olympus' current Exera III series is characterized by better illumination of the bowel lumen and may be associated with a higher ADR than high definition WLC.
Methods:
Investigators performed a prospective evaluation in patients referred to the Department of Interdisciplinary Endoscopy at Jena University Hospital for screening or surveillance colonoscopy between January and November 2015 in daily clinical practice. Colonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal of the colonoscope (Exera III series, Olympus Corporation).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD white light | Active comparator | Device: HD white light or NBIColonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal |
| HD narrow band imaging | Active comparator | Device: HD white light or NBIColonoscopy was performed by use of HD-WLC or HD-NBI upon withdrawal |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Screening colonoscopies
Key exclusion criteria (2 listed)
- Insufficient bowel cleansing
- Age under 55years
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 |
|---|---|---|
| HD white light or NBIUse of NBI or HD white light | Device | HD narrow band imaging, HD white light |
Primary outcome
Adenoma detection rate
Time frame: up to 60min
Adenoma detection rate
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 20 Mar 2018.
- Derived from this study: PubMed 35960070Burger M, Weber M, Petersen I, Stallmach A, Schmidt C. Adenoma detection rate using narrow-band imaging is inferior to high-definition white light colonoscopy in screening and surveillance colonoscopies in daily clinical care: A randomized controlled trial. Medicine (Baltimore). 2022 Aug 12;101(32):e29858. doi: 10.1097/MD.0000000000029858.
- Individual participant dataSharing planned: No
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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.
Carsten Schmidt, MD study director
University Clinic Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD white light or NBI in people with Narrow Band Imaging, run by Jena University Hospital at 1 site in Germany.
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 2 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 20 Mar 2018. 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 Germany. 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: up to 60min). 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 NCT03081975, 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 20 Mar 2018.