Colonic PolypsNCT01638091
Practice-Based Learning to Predict Polyp Histology at Colonoscopy
A study testing Ex vivo module and In vivo practice-base learning phase in people with Colonic Polyps and Adenomatous Polyps, run by Stanford University at 2 sites in United States.
Trial summary
Most colorectal cancers arise from polyps. Most polyps removed at colonoscopy are small. New technologies such as narrowband imaging (NBI) offer the possibility of in differentiation between precancerous and unimportant small polyps. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyps, Adenomatous Polyps
- What is being tested?
- Ex vivo module and In vivo practice-base learning phase
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Mar 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Community-based endoscopist who performs screening colonoscopy
Who cannot join
- Inability or lack of willingness to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Huron Gastroenterology
Ann Arbor, Michigan, 48106
Stanford University
Stanford, California, 94305
About this study
Official title: Practice-Based Learning to Predict Polyp Histology at Colonoscopy: A Demonstration Project in Community Practice
Most colorectal cancers arise from polyps. Most polyps removed at colonoscopy are small. New technologies such as narrowband imaging (NBI) offer the possibility of in differentiation between precancerous and unimportant small polyps. Use of these technologies could decrease the costs and potentially the risks of screening and surveillance colonoscopy.
Multiple studies have demonstrated the ability of experienced endoscopists to achieve high accuracy in differentiating polyp types using NBI.
Read more
The investigators hypothesize that community-based endoscopists can learn to identify polyp type at colonoscopy with the aid of NBI through the use of an introductory didactic program, followed by practice based-learning, and that their experience can serve as guidelines for wider dissemination.
The purpose of this study is to test an educational program combining a didactic program followed by practice-based learning that is designed to allow community-based endoscopists to become proficient at the use of NBI in the colon. This study will not affect the care of patients in any way. The research subjects will be the endoscopists, who will perform colonoscopy and polyp removal in the usual clinical fashion, with the addition of attempting to predict polyp type before resection.
Read the detailed description
- Study Purpose and Rationale Most polyps removed at colonoscopy are small. The natural history of these polyps is not understood completely, but the risk of subsequent cancer in persons with small rectosigmoid adenomas may not be higher than in persons without rectosigmoid adenomas [1]. With improvements in colonoscopic imaging, experienced endoscopists can detect polyps in a large fraction of patients. Removal of all small polyps followed by formal histopathological examination increases the costs associated with colorectal cancer screening, and may increase the risk of complications, depending on the technique that is used for polypectomy.
New technologies such as narrowband imaging (NBI) offer the possibility of in vivo differentiation between adenomatous and hyperplastic polyps. Policies to leave in place small polyps that appear to be hyperplastic, or to remove and discard small polyps after in vivo histologic categorization without formal histopathology review could significantly decrease the costs and potentially the risks of screening and surveillance colonoscopy.
Multiple studies have demonstrated the ability of experienced endoscopists to achieve high accuracy in differentiating adenomatous from hyperplastic polyps using NBI [2, 3, 4, 5]. The level of confidence associated with in vivo histologic categorization of a particular polyp is a valuable adjunct measure in determining subsequent clinical management. Dissemination to the community setting of policies that promote in vivo histologic categorization is likely to require practice-based learning.
- Hypotheses The investigators hypothesize that community-based endoscopists can learn to identify polyp histology at colonoscopy with the aid of NBI through the use of an introductory didactic program, followed by practice based-learning, and that representative learning curves can be generated that can serve as guidelines for wider dissemination.
- Purpose The purpose of this study is to test an educational program combining a didactic program followed by practice-based learning that is designed to allow community-based endoscopists to become proficient at in vivo histologic characterization of small polyps with the aid of NBI. This study will not require any changes in endoscopists' decisions regarding the indications and methods for polypectomy.
This study will not address directly whether polyps predicted to be hyperplastic or even diminutive adenomas should be left in place, or discarded and not submitted for formal histopathological review.
- Specific Aims This study has two primary and two secondary aims
- One primary aim is to assess the proficiency of community-based endoscopists at ex vivo histologic characterization of polyps using NBI based on photographs before and after a didactic program designed to familiarize them with in vivo histologic characterization.
- The central primary aim is to assess whether the currently designed program is effective at training endoscopists to classify adenomatous vs. hyperplastic polyps in practice with at least 90% accuracy.
- A secondary aim is to characterize endoscopists' individual and group average learning curves for in vivo histologic characterization using NBI during practice-based learning, with attention to level of confidence, accuracy, sensitivity, specificity and positive and negative predictive values.
- Another secondary aim is to determine whether surveillance recommendations that would be made based on in vivo histologic characterization using NBI are comparable to those based on formal histopathological assessment.
- Timeline for assessments:
Endoscopists' accuracy will be determined at three pre-specified points: after assessment of 50, 70 and 90 independent diminutive polyps (defined as <=5mm polyps, one per study colonoscopy, with random selection in cases of >1 diminutive polyp per study colonoscopy). We estimate that in order to assess 90 independent diminutive polyps, endoscopists will need to participate for 6-12 months.
- Conditions
- Colonic Polyps, Adenomatous Polyps
- Being tested
- Ex vivo module, In vivo practice-base learning phase
- Keywords
- Narrow band imaging, Screening colonoscopy, Histology
- Medical subject headings
- Colonic Polyps, Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex vivo moduleBehavioural
Pre-test, ex vivo computerized training module, post-test
In vivo practice-base learning phaseBehavioural
Prediction of polyp histology in real time, comparison to pathology reports, and review of cumulative individual performance.
| Study group | Role | What they receive |
|---|---|---|
| All participating endoscopists | Experimental | All endoscopists will undergo ex vivo training and will participate in in vivo practice-based learning. Receives: Behavioral: Ex vivo module; Behavioral: In vivo practice-base learning phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving 90% accuracy
Success for a participant was defined as achieving ≥90% accuracy in optical diagnosis of diminutive polyps. This was based on the last 30 consecutive independent diminutive polyps per participant at one of three pre-specified points (at polyp #50, 70 or 90).
Measured: 6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps
Secondary outcomes (2)
Learning curves
Leraning curves as a function of polyp batch, for sensitivity, specificity, positive and negative predictive values, and accuracy
Measured: 6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps
Surveillance recommendations
Agreement between NBI-aided surveillance recommendations vs. those based on pathology examination of all polyps
Measured: 6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startMar 2011
- Primary completionMar 2012
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 Colonic PolypsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638091
- Sponsor's protocol ID
- HSR-10-1167
- Other IDs
- IRB-20373
- Status last verified
- Jul 2012
- First submitted
- 6 Jul 2012
- Last updated
- 11 Jul 2012
- 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 23041328
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice-Based Learning to Predict Polyp Histology at Colonoscopy: A Demonstration Project in Community Practice
- ClinicalTrials.gov ID
- NCT01638091
- Acronym / sponsor ID
- HSR-10-1167
- Conditions
- Colonic Polyps, Adenomatous Polyps
- Keywords
- Narrow band imaging, Screening colonoscopy, Histology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- First posted
- 11 Jul 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.
Most colorectal cancers arise from polyps. Most polyps removed at colonoscopy are small. New technologies such as narrowband imaging (NBI) offer the possibility of in differentiation between precancerous and unimportant small polyps. Use of these technologies could decrease the costs and potentially the risks of screening and surveillance colonoscopy.
Multiple studies have demonstrated the ability of experienced endoscopists to achieve high accuracy in differentiating polyp types using NBI.
The investigators hypothesize that community-based endoscopists can learn to identify polyp type at colonoscopy with the aid of NBI through the use of an introductory didactic program, followed by practice based-learning, and that their experience can serve as guidelines for wider dissemination.
The purpose of this study is to test an educational program combining a didactic program followed by practice-based learning that is designed to allow community-based endoscopists to become proficient at the use of NBI in the colon. This study will not affect the care of patients in any way. The research subjects will be the endoscopists, who will perform colonoscopy and polyp removal in the usual clinical fashion, with the addition of attempting to predict polyp type before resection.
Detailed description
- Study Purpose and Rationale Most polyps removed at colonoscopy are small. The natural history of these polyps is not understood completely, but the risk of subsequent cancer in persons with small rectosigmoid adenomas may not be higher than in persons without rectosigmoid adenomas [1]. With improvements in colonoscopic imaging, experienced endoscopists can detect polyps in a large fraction of patients. Removal of all small polyps followed by formal histopathological examination increases the costs associated with colorectal cancer screening, and may increase the risk of complications, depending on the technique that is used for polypectomy.
New technologies such as narrowband imaging (NBI) offer the possibility of in vivo differentiation between adenomatous and hyperplastic polyps. Policies to leave in place small polyps that appear to be hyperplastic, or to remove and discard small polyps after in vivo histologic categorization without formal histopathology review could significantly decrease the costs and potentially the risks of screening and surveillance colonoscopy.
Multiple studies have demonstrated the ability of experienced endoscopists to achieve high accuracy in differentiating adenomatous from hyperplastic polyps using NBI [2, 3, 4, 5]. The level of confidence associated with in vivo histologic categorization of a particular polyp is a valuable adjunct measure in determining subsequent clinical management. Dissemination to the community setting of policies that promote in vivo histologic categorization is likely to require practice-based learning.
- Hypotheses The investigators hypothesize that community-based endoscopists can learn to identify polyp histology at colonoscopy with the aid of NBI through the use of an introductory didactic program, followed by practice based-learning, and that representative learning curves can be generated that can serve as guidelines for wider dissemination.
- Purpose The purpose of this study is to test an educational program combining a didactic program followed by practice-based learning that is designed to allow community-based endoscopists to become proficient at in vivo histologic characterization of small polyps with the aid of NBI. This study will not require any changes in endoscopists' decisions regarding the indications and methods for polypectomy.
This study will not address directly whether polyps predicted to be hyperplastic or even diminutive adenomas should be left in place, or discarded and not submitted for formal histopathological review.
- Specific Aims This study has two primary and two secondary aims
- One primary aim is to assess the proficiency of community-based endoscopists at ex vivo histologic characterization of polyps using NBI based on photographs before and after a didactic program designed to familiarize them with in vivo histologic characterization.
- The central primary aim is to assess whether the currently designed program is effective at training endoscopists to classify adenomatous vs. hyperplastic polyps in practice with at least 90% accuracy.
- A secondary aim is to characterize endoscopists' individual and group average learning curves for in vivo histologic characterization using NBI during practice-based learning, with attention to level of confidence, accuracy, sensitivity, specificity and positive and negative predictive values.
- Another secondary aim is to determine whether surveillance recommendations that would be made based on in vivo histologic characterization using NBI are comparable to those based on formal histopathological assessment.
- Timeline for assessments:
Endoscopists' accuracy will be determined at three pre-specified points: after assessment of 50, 70 and 90 independent diminutive polyps (defined as <=5mm polyps, one per study colonoscopy, with random selection in cases of >1 diminutive polyp per study colonoscopy). We estimate that in order to assess 90 independent diminutive polyps, endoscopists will need to participate for 6-12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participating endoscopists | Experimental | Behavioral: Ex vivo module, Behavioral: In vivo practice-base learning phaseAll endoscopists will undergo ex vivo training and will participate in in vivo practice-based learning. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Community-based endoscopist who performs screening colonoscopy
Key exclusion criteria (1 listed)
- Inability or lack of willingness to provide informed consent
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 |
|---|---|---|
| Ex vivo modulePre-test, ex vivo computerized training module, post-test | Behavioural | All participating endoscopists |
| In vivo practice-base learning phasePrediction of polyp histology in real time, comparison to pathology reports, and review of cumulative individual performance. | Behavioural | All participating endoscopists |
Primary outcome
Proportion of participants achieving 90% accuracy
Time frame: 6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps
Success for a participant was defined as achieving ≥90% accuracy in optical diagnosis of diminutive polyps. This was based on the last 30 consecutive independent diminutive polyps per participant at one of three pre-specified points (at polyp #50, 70 or 90).
2 secondary outcomes
Learning curves
Time frame: 6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps
Surveillance recommendations
Time frame: 6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps
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 11 Jul 2012.
- Derived from this study: 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.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ex vivo module and In vivo practice-base learning phase in people with Colonic Polyps and Adenomatous Polyps, run by Stanford University 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 1 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 11 Jul 2012. 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?
Proportion of participants achieving 90% accuracy (time frame: 6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps). 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 NCT01638091, 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 11 Jul 2012.