Colorectal CancerNCT02441998
Real-Time Characterizations of Diminutive Colorectal Polyps Using Narrow Band Imaging
An observational study of Colorectal Cancer, run by University of Michigan.
Trial summary
Colorectal cancer is the second leading cause of cancer related death in the United States. Colonoscopy is the most commonly performed screening procedure and diminutive polyps (<5mm) are the most commonly found polyps during colonoscopy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Education intervention: Training in Narrow Band Imaging
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Practicing gastroenterologists from 2 academic medical centers
Who may be able to join
- Active member of division of Gastroenterology
- Performs colonoscopy
- No prior training in Narrow Band Imaging
- Informed consent to participate
Who cannot join
- Low annual colonoscopy volume (<200 per year)
About this study
Official title: Prospective Multi-Center Study Evaluating Real-Time Characterizations of Diminutive Colorectal Polyps Using Narrow Band Imaging: Implications for the Resect and Discard Strategy
Colorectal cancer is the second leading cause of cancer related death in the United States. Colonoscopy is the most commonly performed screening procedure and diminutive polyps (<5mm) are the most commonly found polyps during colonoscopy. Although these polyps have a very low risk of harboring malignancy, they are routinely removed to determine surveillance intervals.
Narrow Band Imaging is equipped on widely available colonoscopes and in expert hands can allow accurate real-time optical histologic diagnosis of colorectal polyps. If this practice can be applied widely, there is significant potential for cost savings.
Read more
This has led to a 'characterize, resect and discard' strategy where polyps determined to be hyperplastic (benign with no neoplastic potential) can be left in place and those determined to be adenomatous (have neoplastic potential) can be resected and discarded.
It is unclear if endoscopists without prior expertise or training in Narrow Band Imaging can achieve adequate diagnostic accuracy to put 'characterize, resect and discard' into wide practice.
Read the detailed description
Gastroenterologists without prior training in NBI from two affiliated academic hospitals will participate in an ex-vivo training session in which they will view a short audiovisual tool describing previously validated NBI criteria to determine polyp histology, followed by reviewing 80 videos of diminutive polyps under NBI and will record predicted polyp histology and degree of confidence. After each video, targeted feedback regarding actual polyp histology and NBI criteria supporting the diagnosis will be provided. Participants will then employ NBI in real-time colonoscopy (in-vivo) and record predicted polyp histology, degree of confidence and predicted surveillance intervals based on NBI interpretations. Each study polyp will be sent for histology separately. Performance will be assessed by comparing predicted histology with actual histology. Structured performance feedback will be given to promote practice-based learning, establish a real-time learning curve and determine the number of observations required to achieve competency in-vivo.
The primary aim of this study was to determine whether endoscopists with no prior experience or training in Narrow Band Imaging can achieve the thresholds set forth by the American Society of Gastrointestinal Endoscopy: For diminutive colorectal polyp diagnoses made with 'high-confidence,' a (1) greater than or equal to 90% negative predictive value in the rectosigmoid colon and a (2) greater than or equal to 90% agreement in surveillance intervals predicted by narrow band imaging and those based on the current gold standard of histology.
The secondary outcomes for the in-vivo phase included (1) evaluating overall group performance (accuracy, sensitivity, specificity, predictive values) of optical diagnoses using NBI based on degree of confidence and location within the colon, (2) evaluating individual performance on the ASGE benchmarks, (3) determining predictors of performance, and (4) determining real-time learning effect in the setting of ongoing, structured performance feedback. The secondary outcomes for the ex-vivo (training) phase included (1) evaluating overall performance by degree of confidence, (2) determining predictors of performance during training and (3) evaluating a learning effect in the setting of ongoing feedback during training.
Sample size was calculated to show an NPV of 90% or higher assuming that the true NPV is 95% for rectosigmoid polyps characterized with "high-confidence," based on 26 participating endoscopists and within-endoscopist correlation of 0.05. This will require 336 total rectosigmoid non-adenoma polyps characterized with "high-confidence," and assuming approximately 22% rectosigmoid polyps, 70% with high confidence and 80% hyperplastic, the study will require approximately 2,727 polyps and 1,364 colonoscopies in total, assuming approximately two polyps per colonoscopy.
- Conditions
- Colorectal Cancer
- Being tested
- Education intervention: Training in Narrow Band Imaging
- Keywords
- Colorectal Cancer, Diminutive Polyps, Narrow Band Imaging, Colonic Polyps, colonoscopy, diagnostic imaging, optical diagnosis
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education intervention: Training in Narrow Band ImagingOther
Two hour training session in interpretation and application of narrow band imaging technology
What is being measured
The primary outcome is the main question the study is designed to answer.
ASGE PIVI Thresholds: >90% NPV in rectosigmoid, > 90% agreement in surveillance intervals
Measured: 1 year
Secondary outcomes (2)
In vivo overall and individual performance assessed by accuracy, sensitivity, specificity, positive predictive value, negative predictive value
Measured: 1 year
Ex vivo overall and individual performance assessed by accuracy, sensitivity, specificity, positive predictive value, negative predictive value
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Swati Patel, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441998
- Sponsor's protocol ID
- 131998
- Status last verified
- May 2015
- First submitted
- 8 May 2015
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ladabaum U, Fioritto A, Mitani A, Desai M, Kim JP, Rex DK, Imperiale T, Gunaratnam N. Real-time optical biopsy of colon polyps with narrow band imaging in community practice does not yet meet key thresholds for clinical decisions. Gastroenterology. 2013 Jan;144(1):81-91. doi: 10.1053/j.gastro.2012.09.054. Epub 2012 Oct 3.
PubMed 23041328Patel SG, Rastogi A, Austin G, Hall M, Siller BA, Berman K, Yen R, Bansal A, Ahnen DJ, Wani S. Gastroenterology trainees can easily learn histologic characterization of diminutive colorectal polyps with narrow band imaging. Clin Gastroenterol Hepatol. 2013 Aug;11(8):997-1003.e1. doi: 10.1016/j.cgh.2013.02.020. Epub 2013 Mar 1.
PubMed 23466714Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10.
PubMed 19187781Rastogi A, Keighley J, Singh V, Callahan P, Bansal A, Wani S, Sharma P. High accuracy of narrow band imaging without magnification for the real-time characterization of polyp histology and its comparison with high-definition white light colonoscopy: a prospective study. Am J Gastroenterol. 2009 Oct;104(10):2422-30. doi: 10.1038/ajg.2009.403. Epub 2009 Jul 7.
PubMed 19584829Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.
PubMed 19910250ASGE Technology Committee; Abu Dayyeh BK, Thosani N, Konda V, Wallace MB, Rex DK, Chauhan SS, Hwang JH, Komanduri S, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Banerjee S. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2015 Mar;81(3):502.e1-502.e16. doi: 10.1016/j.gie.2014.12.022. Epub 2015 Jan 16.
PubMed 25597420Patel SG, Schoenfeld P, Kim HM, Ward EK, Bansal A, Kim Y, Hosford L, Myers A, Foster S, Craft J, Shopinski S, Wilson RH, Ahnen DJ, Rastogi A, Wani S. Real-Time Characterization of Diminutive Colorectal Polyp Histology Using Narrow-Band Imaging: Implications for the Resect and Discard Strategy. Gastroenterology. 2016 Feb;150(2):406-18. doi: 10.1053/j.gastro.2015.10.042. Epub 2015 Oct 30.
PubMed 26522260
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Center Study Evaluating Real-Time Characterizations of Diminutive Colorectal Polyps Using Narrow Band Imaging: Implications for the Resect and Discard Strategy
- ClinicalTrials.gov ID
- NCT02441998
- Acronym / sponsor ID
- 131998
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Diminutive Polyps, Narrow Band Imaging, Colonic Polyps, colonoscopy, diagnostic imaging, optical diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 May 2015 (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.
Colorectal cancer is the second leading cause of cancer related death in the United States. Colonoscopy is the most commonly performed screening procedure and diminutive polyps (<5mm) are the most commonly found polyps during colonoscopy. Although these polyps have a very low risk of harboring malignancy, they are routinely removed to determine surveillance intervals.
Narrow Band Imaging is equipped on widely available colonoscopes and in expert hands can allow accurate real-time optical histologic diagnosis of colorectal polyps. If this practice can be applied widely, there is significant potential for cost savings.
This has led to a 'characterize, resect and discard' strategy where polyps determined to be hyperplastic (benign with no neoplastic potential) can be left in place and those determined to be adenomatous (have neoplastic potential) can be resected and discarded.
It is unclear if endoscopists without prior expertise or training in Narrow Band Imaging can achieve adequate diagnostic accuracy to put 'characterize, resect and discard' into wide practice.
Detailed description
Gastroenterologists without prior training in NBI from two affiliated academic hospitals will participate in an ex-vivo training session in which they will view a short audiovisual tool describing previously validated NBI criteria to determine polyp histology, followed by reviewing 80 videos of diminutive polyps under NBI and will record predicted polyp histology and degree of confidence. After each video, targeted feedback regarding actual polyp histology and NBI criteria supporting the diagnosis will be provided. Participants will then employ NBI in real-time colonoscopy (in-vivo) and record predicted polyp histology, degree of confidence and predicted surveillance intervals based on NBI interpretations. Each study polyp will be sent for histology separately. Performance will be assessed by comparing predicted histology with actual histology. Structured performance feedback will be given to promote practice-based learning, establish a real-time learning curve and determine the number of observations required to achieve competency in-vivo.
The primary aim of this study was to determine whether endoscopists with no prior experience or training in Narrow Band Imaging can achieve the thresholds set forth by the American Society of Gastrointestinal Endoscopy: For diminutive colorectal polyp diagnoses made with 'high-confidence,' a (1) greater than or equal to 90% negative predictive value in the rectosigmoid colon and a (2) greater than or equal to 90% agreement in surveillance intervals predicted by narrow band imaging and those based on the current gold standard of histology.
The secondary outcomes for the in-vivo phase included (1) evaluating overall group performance (accuracy, sensitivity, specificity, predictive values) of optical diagnoses using NBI based on degree of confidence and location within the colon, (2) evaluating individual performance on the ASGE benchmarks, (3) determining predictors of performance, and (4) determining real-time learning effect in the setting of ongoing, structured performance feedback. The secondary outcomes for the ex-vivo (training) phase included (1) evaluating overall performance by degree of confidence, (2) determining predictors of performance during training and (3) evaluating a learning effect in the setting of ongoing feedback during training.
Sample size was calculated to show an NPV of 90% or higher assuming that the true NPV is 95% for rectosigmoid polyps characterized with "high-confidence," based on 26 participating endoscopists and within-endoscopist correlation of 0.05. This will require 336 total rectosigmoid non-adenoma polyps characterized with "high-confidence," and assuming approximately 22% rectosigmoid polyps, 70% with high confidence and 80% hyperplastic, the study will require approximately 2,727 polyps and 1,364 colonoscopies in total, assuming approximately two polyps per colonoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Practicing gastroenterologists from 2 academic medical centers
Key inclusion criteria (4 listed)
- Active member of division of Gastroenterology
- Performs colonoscopy
- No prior training in Narrow Band Imaging
- Informed consent to participate
Key exclusion criteria (1 listed)
- Low annual colonoscopy volume (<200 per year)
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 |
|---|---|---|
| Education intervention: Training in Narrow Band ImagingTwo hour training session in interpretation and application of narrow band imaging technology | Other | – |
Primary outcome
ASGE PIVI Thresholds: >90% NPV in rectosigmoid, > 90% agreement in surveillance intervals
Time frame: 1 year
2 secondary outcomes
In vivo overall and individual performance assessed by accuracy, sensitivity, specificity, positive predictive value, negative predictive value
Time frame: 1 year
Ex vivo overall and individual performance assessed by accuracy, sensitivity, specificity, positive predictive value, negative predictive value
Time frame: 1 year
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 May 2015.
- Background: PubMed 23041328Ladabaum U, Fioritto A, Mitani A, Desai M, Kim JP, Rex DK, Imperiale T, Gunaratnam N. Real-time optical biopsy of colon polyps with narrow band imaging in community practice does not yet meet key thresholds for clinical decisions. Gastroenterology. 2013 Jan;144(1):81-91. doi: 10.1053/j.gastro.2012.09.054. Epub 2012 Oct 3.
- Background: PubMed 23466714Patel SG, Rastogi A, Austin G, Hall M, Siller BA, Berman K, Yen R, Bansal A, Ahnen DJ, Wani S. Gastroenterology trainees can easily learn histologic characterization of diminutive colorectal polyps with narrow band imaging. Clin Gastroenterol Hepatol. 2013 Aug;11(8):997-1003.e1. doi: 10.1016/j.cgh.2013.02.020. Epub 2013 Mar 1.
- Background: PubMed 19187781Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10.
- Background: PubMed 19584829Rastogi A, Keighley J, Singh V, Callahan P, Bansal A, Wani S, Sharma P. High accuracy of narrow band imaging without magnification for the real-time characterization of polyp histology and its comparison with high-definition white light colonoscopy: a prospective study. Am J Gastroenterol. 2009 Oct;104(10):2422-30. doi: 10.1038/ajg.2009.403. Epub 2009 Jul 7.
- Background: PubMed 19910250Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.
- Background: PubMed 25597420ASGE Technology Committee; Abu Dayyeh BK, Thosani N, Konda V, Wallace MB, Rex DK, Chauhan SS, Hwang JH, Komanduri S, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Banerjee S. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2015 Mar;81(3):502.e1-502.e16. doi: 10.1016/j.gie.2014.12.022. Epub 2015 Jan 16.
- Derived from this study: PubMed 26522260Patel SG, Schoenfeld P, Kim HM, Ward EK, Bansal A, Kim Y, Hosford L, Myers A, Foster S, Craft J, Shopinski S, Wilson RH, Ahnen DJ, Rastogi A, Wani S. Real-Time Characterization of Diminutive Colorectal Polyp Histology Using Narrow-Band Imaging: Implications for the Resect and Discard Strategy. Gastroenterology. 2016 Feb;150(2):406-18. doi: 10.1053/j.gastro.2015.10.042. Epub 2015 Oct 30.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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?
An observational study of Colorectal Cancer, run by University of Michigan.
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 4 inclusion and 1 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 May 2015. 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?
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?
ASGE PIVI Thresholds: >90% NPV in rectosigmoid, > 90% agreement in surveillance intervals (time frame: 1 year). 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 NCT02441998, which also lists 7 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 13 May 2015.