Adenomatous PolypNCT00614770
Narrow Band Imaging Colon Polyp Study
A study testing colonoscopy in people with Adenomatous Polyp and New Imaging Techniques in Colonoscopy, run by Kansas City Veteran Affairs Medical Center at 2 sites in United States.
Trial summary
In this study the investigators hypothesize that High Definition White Light colonoscopy and narrow band imaging (NBI) will detect a higher number of adenomas compared to standard definition white light colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adenomatous Polyp, New Imaging Techniques in Colonoscopy
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Dec 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- referral for screening or surveillance colonoscopy
- the ability to provide informed consent
Who cannot join
- prior surgical resection of any portion of colon
- prior history of colon cancer
- history of inflammatory bowel disease
- use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
- poor general condition or any other reason to avoid prolonged procedure time
- history of polyposis syndrome or HNPCC
- inability to give informed consent.
- Inadequate bowel preparation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Trial for the Detection of Colon Polyps and Predicting Histology
In this study the investigators hypothesize that High Definition White Light colonoscopy and narrow band imaging (NBI) will detect a higher number of adenomas compared to standard definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp histology compared to high definition colonoscopy and standard colonoscopy.
Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy, high-definition white light colonoscopy and NBI.
Read more
Specific Aim 2 - To compare the number of adenoma detected per subject by standard colonoscopy, high-definition white light colonoscopy and NBI.
Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface mucosal and vascular patterns during the procedure.
Specific Aim 4 - To determine the inter-observer agreement between investigators for the recognition of various polyp patterns
Read the detailed description
This study is a multi-center randomized controlled trial that will be conducted at the Kansas City VA Medical Center, Kansas City, MO and The Barnes Jewish Hospital, St Louis, MO. Patients referred for screening and surveillance colonoscopy will be enrolled. They will be randomized to one of the following three groups: standard white light colonoscopy, high-definition white light colonoscopy or NBI.
All colonoscopies will be performed at the Kansas City VA Medical Center and The Barnes Jewish Hospital, St Louis, MO. Moderate sedation will be administered for the procedure with intravenous midazolam, demerol or fentanyl and Propofol. In patients randomized to the NBI arm, the colonoscope will be inserted to the cecum under white light and will switch to NBI mode at the time of withdrawal. After cecal intubation, the colonic mucosa will be carefully visualized during withdrawal of the scope with one of the three imaging modalities to which the patient has been randomized. No effort will be made to look for polyps during the insertion of the colonoscope. All polyps detected will be documented for their size, morphology (Polypoid: sessile, pedunculated or Non polypoid: superficially elevated, completely flat, depressed), and location. The surface of the polyp will be assessed during the procedure and the histology will be predicted real time by evaluating the surface mucosal and vascular patterns. The patterns would be classified into one of the four patterns described in our pilot study (tubular and gyrus patterns will be combined to tubulogyrus pattern). Any other patterns detected would be described and kept in the miscellaneous category. If a pattern is not identified on a polyp with either white light or NBI, it will be recorded as such and no attempts will be made to predict histology. Photo documentation of the surface patterns of the polyps will be performed. Polyps will then be removed either with a biopsy forcep or snare and sent for histopathological evaluation. Each polyp removed will have one or more corresponding picture of its surface patterns and these will be labeled accordingly. The total time spent in inspecting the colonic mucosa (excluding the time spent in removal of polyps or clearing the colon of liquid and solid debris) will be measured with a stop watch. Representative images of the various polyp patterns will be reviewed, discussed and standardized amongst all the investigators at both sites. In addition, images of all the polyp patterns will be printed and posted in the endoscopy suites at both hospitals.
The bowel preparation will be evaluated and graded as follow:
Excellent (score=1) - >90% mucosa seen, mostly liquid colonic contents, minimal suctioning needed for adequate visualization.
Good (score=2) - >90% of mucosa seen, mostly liquid colonic contents, significant suctioning needed for adequate visualization Fair (score=3) - > 90% mucosa seen, mixture of liquid and semisolid colonic contents, could be suctioned and/or washed Inadequate (score=4) - <90% mucosa seen, mixture of semisolid ands solid colonic contents, which could not be suctioned or washed
Patients with "Inadequate" (score = 4) bowel prep will be excluded.
- Being tested
- standard of care colonoscopy, colonoscopy
- Keywords
- colonoscopy
- Medical subject headings
- Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of care colonoscopyProcedure or surgery
Standard White Light Colonoscopy
one exam per patient
colonoscopyProcedure or surgery
Narrow Band Imaging Colonoscopy
one exam per patient
standard of care colonoscopyProcedure or surgery
High Definition White Light Colonoscopy
one exam per patient
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Standard White Light Colonoscopy Receives: Procedure: standard of care colonoscopy |
| 2 | Experimental | High Definition White Light Colonoscopy Receives: Procedure: standard of care colonoscopy |
| 3 | Experimental | Narrow Band Imaging Colonoscopy Receives: Procedure: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of adenomas in the three arms of the study.
Number of subjects with adenomas in the three arms of the study
Measured: 2 years
Secondary outcomes (1)
Secondary outcome will be number of adenomas detected per subject in the three arms, the sensitivity, specificity, and accuracy of predicting polyp histology real time by the three imaging modalities.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2009
- Study completionDec 2009
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 Adenomatous PolypStudies 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
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas City Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- American Society for Gastrointestinal Endoscopy, Midwest Biomedical Research
- Investigators
- Amit Rastogi, MD, Principal investigator, Kansas City VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614770
- Sponsor's protocol ID
- AR0003
- Other IDs
- AR0003
- Status last verified
- Jun 2010
- First submitted
- 31 Jan 2008
- Last updated
- 17 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Rastogi A, Early DS, Gupta N, Bansal A, Singh V, Ansstas M, Jonnalagadda SS, Hovis CE, Gaddam S, Wani SB, Edmundowicz SA, Sharma P. Randomized, controlled trial of standard-definition white-light, high-definition white-light, and narrow-band imaging colonoscopy for the detection of colon polyps and prediction of polyp histology. Gastrointest Endosc. 2011 Sep;74(3):593-602. doi: 10.1016/j.gie.2011.04.050. Epub 2011 Jul 29.
PubMed 21802078
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Trial for the Detection of Colon Polyps and Predicting Histology
- ClinicalTrials.gov ID
- NCT00614770
- Acronym / sponsor ID
- AR0003
- Keywords
- colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Kansas City Veteran Affairs Medical CenterUS federal agency
- Collaborators
- American Society for Gastrointestinal Endoscopy, Midwest Biomedical Research
- Study start
- Feb 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Feb 2008 (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.
In this study the investigators hypothesize that High Definition White Light colonoscopy and narrow band imaging (NBI) will detect a higher number of adenomas compared to standard definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp histology compared to high definition colonoscopy and standard colonoscopy.
Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy, high-definition white light colonoscopy and NBI.
Specific Aim 2 - To compare the number of adenoma detected per subject by standard colonoscopy, high-definition white light colonoscopy and NBI.
Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface mucosal and vascular patterns during the procedure.
Specific Aim 4 - To determine the inter-observer agreement between investigators for the recognition of various polyp patterns
Detailed description
This study is a multi-center randomized controlled trial that will be conducted at the Kansas City VA Medical Center, Kansas City, MO and The Barnes Jewish Hospital, St Louis, MO. Patients referred for screening and surveillance colonoscopy will be enrolled. They will be randomized to one of the following three groups: standard white light colonoscopy, high-definition white light colonoscopy or NBI.
All colonoscopies will be performed at the Kansas City VA Medical Center and The Barnes Jewish Hospital, St Louis, MO. Moderate sedation will be administered for the procedure with intravenous midazolam, demerol or fentanyl and Propofol. In patients randomized to the NBI arm, the colonoscope will be inserted to the cecum under white light and will switch to NBI mode at the time of withdrawal. After cecal intubation, the colonic mucosa will be carefully visualized during withdrawal of the scope with one of the three imaging modalities to which the patient has been randomized. No effort will be made to look for polyps during the insertion of the colonoscope. All polyps detected will be documented for their size, morphology (Polypoid: sessile, pedunculated or Non polypoid: superficially elevated, completely flat, depressed), and location. The surface of the polyp will be assessed during the procedure and the histology will be predicted real time by evaluating the surface mucosal and vascular patterns. The patterns would be classified into one of the four patterns described in our pilot study (tubular and gyrus patterns will be combined to tubulogyrus pattern). Any other patterns detected would be described and kept in the miscellaneous category. If a pattern is not identified on a polyp with either white light or NBI, it will be recorded as such and no attempts will be made to predict histology. Photo documentation of the surface patterns of the polyps will be performed. Polyps will then be removed either with a biopsy forcep or snare and sent for histopathological evaluation. Each polyp removed will have one or more corresponding picture of its surface patterns and these will be labeled accordingly. The total time spent in inspecting the colonic mucosa (excluding the time spent in removal of polyps or clearing the colon of liquid and solid debris) will be measured with a stop watch. Representative images of the various polyp patterns will be reviewed, discussed and standardized amongst all the investigators at both sites. In addition, images of all the polyp patterns will be printed and posted in the endoscopy suites at both hospitals.
The bowel preparation will be evaluated and graded as follow:
Excellent (score=1) - >90% mucosa seen, mostly liquid colonic contents, minimal suctioning needed for adequate visualization.
Good (score=2) - >90% of mucosa seen, mostly liquid colonic contents, significant suctioning needed for adequate visualization Fair (score=3) - > 90% mucosa seen, mixture of liquid and semisolid colonic contents, could be suctioned and/or washed Inadequate (score=4) - <90% mucosa seen, mixture of semisolid ands solid colonic contents, which could not be suctioned or washed
Patients with "Inadequate" (score = 4) bowel prep will be excluded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: standard of care colonoscopyStandard White Light Colonoscopy |
| 2 | Experimental | Procedure: standard of care colonoscopyHigh Definition White Light Colonoscopy |
| 3 | Experimental | Procedure: colonoscopyNarrow Band Imaging Colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- referral for screening or surveillance colonoscopy
- the ability to provide informed consent
Key exclusion criteria (8 listed)
- prior surgical resection of any portion of colon
- prior history of colon cancer
- history of inflammatory bowel disease
- use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
- poor general condition or any other reason to avoid prolonged procedure time
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 |
|---|---|---|
| standard of care colonoscopyStandard White Light Colonoscopy one exam per patient | Procedure or surgery | 1 |
| colonoscopyNarrow Band Imaging Colonoscopy one exam per patient | Procedure or surgery | 3 |
| standard of care colonoscopyHigh Definition White Light Colonoscopy one exam per patient | Procedure or surgery | 2 |
Primary outcome
The prevalence of adenomas in the three arms of the study.
Time frame: 2 years
Number of subjects with adenomas in the three arms of the study
1 secondary outcome
Secondary outcome will be number of adenomas detected per subject in the three arms, the sensitivity, specificity, and accuracy of predicting polyp histology real time by the three imaging modalities.
Time frame: 2 years
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 17 Jun 2010.
- Derived from this study: PubMed 21802078Rastogi A, Early DS, Gupta N, Bansal A, Singh V, Ansstas M, Jonnalagadda SS, Hovis CE, Gaddam S, Wani SB, Edmundowicz SA, Sharma P. Randomized, controlled trial of standard-definition white-light, high-definition white-light, and narrow-band imaging colonoscopy for the detection of colon polyps and prediction of polyp histology. Gastrointest Endosc. 2011 Sep;74(3):593-602. doi: 10.1016/j.gie.2011.04.050. Epub 2011 Jul 29.
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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.
Amit Rastogi, MD principal investigator
Kansas City VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopy in people with Adenomatous Polyp and New Imaging Techniques in Colonoscopy, run by Kansas City Veteran Affairs Medical Center at 2 sites in United States.
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 8 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 17 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The prevalence of adenomas in the three arms of the study. (time frame: 2 years). 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 NCT00614770, 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 17 Jun 2010.