Colonic PolypsNCT02711475
Evaluation of Colonic Diminutive Polyps With Electronic Filters
An observational study of Colonic Polyps, run by Ospedale Cardinal Massaia at 1 site in Italy.
Trial summary
Diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal polyps encountered during colonoscopy. Since the chance of harboring advanced adenoma or carcinoma in this kind of polyps is very low, a "remove and discard" technique has been proposed. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colonic Polyps
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2017to 1 Jan 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All pationts undergoing screening and non screening colonoscopy
Who may be able to join
- All subjects undergoing colonoscopy
Who cannot join
- Patients assuming oral anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Cardinal Massaia Hospital
Asti, AT, 14100
CARLO VERNA, CONSULTANT, +39141489975, karleorn@gmail.com
About this study
Official title: "Remove and Discard" Policy in Colonic Diminutive Polyps: is it Always Safe?
Diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal polyps encountered during colonoscopy. Since the chance of harboring advanced adenoma or carcinoma in this kind of polyps is very low, a "remove and discard" technique has been proposed.
The differentiation between adenoma/non adenoma polyps is based on the use of endoscopes equipped with high definition, magnification and optical filters.
Read the detailed description
Any diminutive polyps encountered during a colonoscopy will be examined with the use of electronic filters and magnification and assigned by the endoscopist to a adenoma/non adenoma category, resected and retrieved: a follow up surveillance period will be assigned on the basis of the endoscopic appearance of the polyps.
Each polyp will then be sent separately to Pathology for the histologic evaluation, and a surveillance interval period will be determined accordingly.
- Conditions
- Colonic Polyps
- Medical subject headings
- Colonic Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of accordance between endoscopic and histologic assignment of the polyps to the adenoma/non adenoma category
All the retrieved polyps will be examined and the percentage of accordance between the endoscopic and histologic diagnosis will be determined
Measured: 1 year
Secondary outcomes (2)
Cost savings expressed in dollars between the "remove and discard" technique and histologic examination of samples
The cost of histologic examination for any polyp retrieved will be determined according to the current italian tariff of the procedure and the savings will be calculate
Measured: 1 year
Percentage of concordance between the surveillance periods, determined on the basis of the endoscopic and histologic evaluation of the polyps
For any patient, there will be an analysis of the surveillance period assigned both by the endoscopist and the pathologist in order to determine the percentage of accordance between the two.
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 posted17 Mar 2016 (estimated)
- Study start10 Jan 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion1 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Cardinal Massaia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, carlo verna, Ospedale Cardinal Massaia
- Investigators
- CARLO VERNA, M.D., Principal investigator, CARDINAL MASSAIA HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711475
- Sponsor's protocol ID
- OCMAS-1
- Status last verified
- Nov 2017
- First submitted
- 8 Mar 2016
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Murino A, Hassan C, Repici A. The diminutive colon polyp: biopsy, snare, leave alone? Curr Opin Gastroenterol. 2016 Jan;32(1):38-43. doi: 10.1097/MOG.0000000000000230.
PubMed 26574868Repici A, Hassan C, Radaelli F, Occhipinti P, De Angelis C, Romeo F, Paggi S, Saettone S, Cisaro F, Spaander M, Sharma P, Kuipers EJ. Accuracy of narrow-band imaging in predicting colonoscopy surveillance intervals and histology of distal diminutive polyps: results from a multicenter, prospective trial. Gastrointest Endosc. 2013 Jul;78(1):106-14. doi: 10.1016/j.gie.2013.01.035. Epub 2013 Apr 11.
PubMed 23582472Radaelli F. The Resect-and-Discard Strategy for Management of Small and Diminutive Colonic Polyps. Gastroenterol Hepatol (N Y). 2013 May;9(5):305-8. No abstract available.
PubMed 23943666Paggi S, Radaelli F, Repici A, Hassan C. Advances in the removal of diminutive colorectal polyps. Expert Rev Gastroenterol Hepatol. 2015 Feb;9(2):237-44. doi: 10.1586/17474124.2014.950955. Epub 2014 Aug 26.
PubMed 25155348ASGE 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 25597420Rameshshanker R, Wilson A. Electronic Imaging in Colonoscopy: Clinical Applications and Future Prospects. Curr Treat Options Gastroenterol. 2016 Mar;14(1):140-51. doi: 10.1007/s11938-016-0075-1.
PubMed 26923476
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Remove and Discard" Policy in Colonic Diminutive Polyps: is it Always Safe?
- ClinicalTrials.gov ID
- NCT02711475
- Acronym / sponsor ID
- OCMAS-1
- Conditions
- Colonic Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Ospedale Cardinal MassaiaUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 1 Jan 2018 (estimated)
- First posted
- 17 Mar 2016 (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.
Diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal polyps encountered during colonoscopy. Since the chance of harboring advanced adenoma or carcinoma in this kind of polyps is very low, a "remove and discard" technique has been proposed.
The differentiation between adenoma/non adenoma polyps is based on the use of endoscopes equipped with high definition, magnification and optical filters.
Detailed description
Any diminutive polyps encountered during a colonoscopy will be examined with the use of electronic filters and magnification and assigned by the endoscopist to a adenoma/non adenoma category, resected and retrieved: a follow up surveillance period will be assigned on the basis of the endoscopic appearance of the polyps.
Each polyp will then be sent separately to Pathology for the histologic evaluation, and a surveillance interval period will be determined accordingly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All pationts undergoing screening and non screening colonoscopy
Key inclusion criteria (1 listed)
- All subjects undergoing colonoscopy
Key exclusion criteria (1 listed)
- Patients assuming oral anticoagulant therapy
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
Percentage of accordance between endoscopic and histologic assignment of the polyps to the adenoma/non adenoma category
Time frame: 1 year
All the retrieved polyps will be examined and the percentage of accordance between the endoscopic and histologic diagnosis will be determined
2 secondary outcomes
Cost savings expressed in dollars between the "remove and discard" technique and histologic examination of samples
Time frame: 1 year
Percentage of concordance between the surveillance periods, determined on the basis of the endoscopic and histologic evaluation of the polyps
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Background: PubMed 26574868Murino A, Hassan C, Repici A. The diminutive colon polyp: biopsy, snare, leave alone? Curr Opin Gastroenterol. 2016 Jan;32(1):38-43. doi: 10.1097/MOG.0000000000000230.
- Background: PubMed 23582472Repici A, Hassan C, Radaelli F, Occhipinti P, De Angelis C, Romeo F, Paggi S, Saettone S, Cisaro F, Spaander M, Sharma P, Kuipers EJ. Accuracy of narrow-band imaging in predicting colonoscopy surveillance intervals and histology of distal diminutive polyps: results from a multicenter, prospective trial. Gastrointest Endosc. 2013 Jul;78(1):106-14. doi: 10.1016/j.gie.2013.01.035. Epub 2013 Apr 11.
- Background: PubMed 23943666Radaelli F. The Resect-and-Discard Strategy for Management of Small and Diminutive Colonic Polyps. Gastroenterol Hepatol (N Y). 2013 May;9(5):305-8. No abstract available.
- Background: PubMed 25155348Paggi S, Radaelli F, Repici A, Hassan C. Advances in the removal of diminutive colorectal polyps. Expert Rev Gastroenterol Hepatol. 2015 Feb;9(2):237-44. doi: 10.1586/17474124.2014.950955. Epub 2014 Aug 26.
- 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.
- Results publication: PubMed 26923476Rameshshanker R, Wilson A. Electronic Imaging in Colonoscopy: Clinical Applications and Future Prospects. Curr Treat Options Gastroenterol. 2016 Mar;14(1):140-51. doi: 10.1007/s11938-016-0075-1.
- Individual participant dataSharing planned: Undecided
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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.
CARLO VERNA, M.D. principal investigator
CARDINAL MASSAIA HOSPITAL
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 Colonic Polyps, run by Ospedale Cardinal Massaia 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 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: status not confirmed, as of the sponsor's last update on 8 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CARLO VERNA, M.D. (+3914148 ext. 9975, karleorn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of accordance between endoscopic and histologic assignment of the polyps to the adenoma/non adenoma category (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 NCT02711475, which also lists 6 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 8 Nov 2017.