Clinical trial NCT02711475: Evaluation of Colonic Diminutive Polyps With Electronic Filters
Official title: "Remove and Discard" Policy in Colonic Diminutive Polyps: is it Always Safe?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonic Polyps
Lead sponsor: Ospedale Cardinal Massaia
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pationts undergoing screening and non screening colonoscopy

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* All subjects undergoing colonoscopy

Exclusion Criteria:

* Patients assuming oral anticoagulant therapy

Primary outcomes:
measure: Percentage of accordance between endoscopic and histologic assignment of the polyps to the adenoma/non adenoma category
timeFrame: 1 year
Secondary outcomes:
measure: Cost savings expressed in dollars between the "remove and discard" technique and histologic examination of samples
timeFrame: 1 year
measure: Percentage of concordance between the surveillance periods, determined on the basis of the endoscopic and histologic evaluation of the polyps
timeFrame: 1 year
Other outcomes:
Locations:
city: Asti
country: Italy
facility: Cardinal Massaia Hospital
state: AT
Study officials:
affiliation: CARDINAL MASSAIA HOSPITAL
name: CARLO VERNA, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Repici 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.
citation: Radaelli 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.
citation: Paggi 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.
citation: ASGE 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.
citation: Rameshshanker 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.