Evaluation of Colonic Diminutive Polyps With Electronic Filters

• Conditions: Colonic Polyps

• Registration Number: NCT02711475
• Lead Sponsor: Ospedale Cardinal Massaia

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.

Study Timeline

• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-17
• Study Start: 2017-01-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-08
• Primary Completion: 2017-12-31
• Study Completion: 2018-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• All subjects undergoing colonoscopy

Exclusion Criteria

• Patients assuming oral anticoagulant therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of accordance between endoscopic and histologic assignment of the polyps to the adenoma/non adenoma category	1 year	All the retrieved polyps will be examined and the percentage of accordance between the endoscopic and histologic diagnosis will be determined

Secondary Outcome Measures

Name	Time	Method
Percentage of concordance between the surveillance periods, determined on the basis of the endoscopic and histologic evaluation of the polyps	1 year	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.
Cost savings expressed in dollars between the "remove and discard" technique and histologic examination of samples	1 year	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

Trial Locations

Locations (1)

Cardinal Massaia Hospital; 🇮🇹 Asti, AT, Italy