Evaluation of Colonic Diminutive Polyps With Electronic Filters

Colonic Polyps Clinical Trial

Official title:

"Remove and Discard" Policy in Colonic Diminutive Polyps: is it Always Safe?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02711475
• Other study ID #: OCMAS-1
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2016
• Last updated: November 7, 2017
• Start date: January 10, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: November 2017
• Source: Ospedale Cardinal Massaia
• Contact: CARLO VERNA, M.D.
• Phone: +3914148
• Email: karleorn[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

The differentiation between adenoma/non adenoma polyps is based on the use of endoscopes equipped with high definition, magnification and optical filters.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: January 1, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All subjects undergoing colonoscopy

Exclusion Criteria:

• Patients assuming oral anticoagulant therapy

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps

Locations

Country	Name	City	State
Italy	Cardinal Massaia Hospital	Asti	AT

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Cardinal Massaia

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. Review. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Repici A, Hassan C, Radaelli F, Occhipinti P, De Angelis C, Romeo F, Paggi S, Saettone S, Cisarò 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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	1 year
Secondary	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.	1 year