Resect and Discard Strategies for ColonoscopyNCT02196402
Narrow Band Imaging in the Prediction of Surveillance Intervals After Polypectomy in Community Practice: Ready for (a European) Prime Time
An observational study of Resect and Discard Strategies for Colonoscopy, run by Valduce Hospital at 1 site in Italy.
Trial summary
Several reports have suggested that an endoscopic diagnosis of adenoma, by means of narrow band imaging (NBI), might allow the determination of polyp management and surveillance interval, particularly in patients with diminutive polyps (< 5mm), in which the advanced histological features are uncommon and the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Resect and Discard Strategies for Colonoscopy
- How many people
- 280 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2013to Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy for routine indications (screening, symptoms, surveillance). Exclusion criteria: * patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer * patients with inadequate bowel preparation * patients in which cecal intubation was not achieved or scheduled for partial examinations * polyps could not be resected due to ongoing anticoagulation or could not be retrieved for pathologic assessment
Who may be able to join
- Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy for routine indications (screening, symptoms, surveillance).
Who cannot join
- patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
- patients with inadequate bowel preparation
- patients in which cecal intubation was not achieved or scheduled for partial examinations
- polyps could not be resected due to ongoing anticoagulation or could not be retrieved for pathologic assessment
Trial locations and contacts
1 site in 1 country.
About this study
Several reports have suggested that an endoscopic diagnosis of adenoma, by means of narrow band imaging (NBI), might allow the determination of polyp management and surveillance interval, particularly in patients with diminutive polyps (< 5mm), in which the advanced histological features are uncommon and the prevalence of invasive cancer is negligible (1). On this basis, the American Society of Gastrointestinal Endoscopy (ASGE) has set an initiative evaluating the applicability of real-time endoscopic polyp assessment in clinical practice (1), which states that:
- for diminutive polyps to be resected and discarded without pathologic assessment, endoscopic technology (when used with high confidence) used to determine histology of polyps < 5mm in size, when combined with the histopathologic assessment of polyps >5 mm in size, should provide a > 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps.
- In order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps <5 mm in size in place (without resection), the technology should provide > 90% negative predictive value (when used with high confidence) for adenomatous histology
Read more
This strategy could potentially exert a significant impact on colonoscopy practice, by decreasing at some extent pathology-associated costs, although those related to histological analysis of >5mm polyps is maintained.
In a recent study performed in our Centre (2), we restricted the application of the resect and discard strategy to patients with small or diminutive polyps only, achieving an accordance between endoscopy-directed and histology-directed surveillance strategy of about 85% in both populations. This approach, where decisions on patient management are driven only by the "in vivo" endoscopic assessment, provides on one hand a slightly lower accordance than the threshold of 90% set by the PIVI, but on the other one it allows the complete spare of pathology related costs, although for a smaller proportion of patients. Moreover we observed a negative predictive value of 86% for the presence of adenoma within the diminutive polyps cohort, although a separate analysis for left sided ones was not performed.
AIms of this single center, prospective, observational study:
- To prospectively evaluate the accordance between the endoscopy-directed and histology-directed surveillance strategies by applying the resect and discard strategy for diminutive polyps according to the PIVI statements
- To assess the economic impact of the resect and discard strategy when applied either according to the PIVI statements or to restrictedly to subjects with diminutive polyps only
- To provide a temporary validation of diagnostic performances of the resect and discard strategy for our group and the potential presence of a learning effect for the methodology
- Accordance between endoscopists' and nurses' categorization of adenomas according to standardized criteria (see below)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study population | Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy for routine indications (screening, symptoms, surveillance). Exclusion criteria: * patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer * patients with inadequate bowel preparation * patients in which cecal intubation was not achieved or scheduled for partial examinations * polyps could not be resected due to ongoing anticoagulation or could not be retrieved for pathologic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of cases in which the accordance between the endoscopy-directed and histology-directed surveillance strategies by applying the resect and discard strategy for diminutive polyps according to the PIVI statements was observed
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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 Resect and Discard Strategies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaldo Amato, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196402
- Sponsor's protocol ID
- 5/2014
- Status last verified
- Jul 2014
- First submitted
- 16 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Paggi S, Rondonotti E, Amato A, Fuccio L, Andrealli A, Spinzi G, Radaelli F. Narrow-band imaging in the prediction of surveillance intervals after polypectomy in community practice. Endoscopy. 2015 Sep;47(9):808-14. doi: 10.1055/s-0034-1392042. Epub 2015 Jun 12.
PubMed 26070008
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow Band Imaging in the Prediction of Surveillance Intervals After Polypectomy in Community Practice: Ready for (a European) Prime Time
- ClinicalTrials.gov ID
- NCT02196402
- Acronym / sponsor ID
- 5/2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 22 Jul 2014 (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.
Several reports have suggested that an endoscopic diagnosis of adenoma, by means of narrow band imaging (NBI), might allow the determination of polyp management and surveillance interval, particularly in patients with diminutive polyps (< 5mm), in which the advanced histological features are uncommon and the prevalence of invasive cancer is negligible (1). On this basis, the American Society of Gastrointestinal Endoscopy (ASGE) has set an initiative evaluating the applicability of real-time endoscopic polyp assessment in clinical practice (1), which states that:
- for diminutive polyps to be resected and discarded without pathologic assessment, endoscopic technology (when used with high confidence) used to determine histology of polyps < 5mm in size, when combined with the histopathologic assessment of polyps >5 mm in size, should provide a > 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps.
- In order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps <5 mm in size in place (without resection), the technology should provide > 90% negative predictive value (when used with high confidence) for adenomatous histology
This strategy could potentially exert a significant impact on colonoscopy practice, by decreasing at some extent pathology-associated costs, although those related to histological analysis of >5mm polyps is maintained.
In a recent study performed in our Centre (2), we restricted the application of the resect and discard strategy to patients with small or diminutive polyps only, achieving an accordance between endoscopy-directed and histology-directed surveillance strategy of about 85% in both populations. This approach, where decisions on patient management are driven only by the "in vivo" endoscopic assessment, provides on one hand a slightly lower accordance than the threshold of 90% set by the PIVI, but on the other one it allows the complete spare of pathology related costs, although for a smaller proportion of patients. Moreover we observed a negative predictive value of 86% for the presence of adenoma within the diminutive polyps cohort, although a separate analysis for left sided ones was not performed.
AIms of this single center, prospective, observational study:
- To prospectively evaluate the accordance between the endoscopy-directed and histology-directed surveillance strategies by applying the resect and discard strategy for diminutive polyps according to the PIVI statements
- To assess the economic impact of the resect and discard strategy when applied either according to the PIVI statements or to restrictedly to subjects with diminutive polyps only
- To provide a temporary validation of diagnostic performances of the resect and discard strategy for our group and the potential presence of a learning effect for the methodology
- Accordance between endoscopists' and nurses' categorization of adenomas according to standardized criteria (see below)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study population | – | –Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy for routine indications (screening, symptoms, surveillance). Exclusion criteria: * patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer * patients with inadequate bowel preparation * patients in which cecal intubation was not achieved or scheduled for partial examinations * polyps could not be resected due to ongoing anticoagulation or could not be retrieved for pathologic assessment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy for routine indications (screening, symptoms, surveillance). Exclusion criteria: * patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer * patients with inadequate bowel preparation * patients in which cecal intubation was not achieved or scheduled for partial examinations * polyps could not be resected due to ongoing anticoagulation or could not be retrieved for pathologic assessment
Key inclusion criteria (1 listed)
- Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy for routine indications (screening, symptoms, surveillance).
Key exclusion criteria (4 listed)
- patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
- patients with inadequate bowel preparation
- patients in which cecal intubation was not achieved or scheduled for partial examinations
- polyps could not be resected due to ongoing anticoagulation or could not be retrieved for pathologic assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of cases in which the accordance between the endoscopy-directed and histology-directed surveillance strategies by applying the resect and discard strategy for diminutive polyps according to the PIVI statements was observed
Time frame: 4 months
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 22 Jul 2014.
- Derived from this study: PubMed 26070008Paggi S, Rondonotti E, Amato A, Fuccio L, Andrealli A, Spinzi G, Radaelli F. Narrow-band imaging in the prediction of surveillance intervals after polypectomy in community practice. Endoscopy. 2015 Sep;47(9):808-14. doi: 10.1055/s-0034-1392042. Epub 2015 Jun 12.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resect and Discard Strategies for Colonoscopy, run by Valduce Hospital at 1 site in Italy.
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 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 22 Jul 2014. 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 Italy. 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 cases in which the accordance between the endoscopy-directed and histology-directed surveillance strategies by applying the resect and discard strategy for diminutive polyps according to the PIVI statements was observed (time frame: 4 months). 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 NCT02196402, 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 22 Jul 2014.