Accuracy in Resection of Non-pedunculated Colonic Lesions 5-20 mm With/Without Using NBI

Interval colon cancers are an important clinical issue. A recent paper from Pohl et al focused on non-pedunculated polyps of 5-20 mm, evaluating non complete polypectomy revealing that 10% of these polyps were not completely resected. This fact was attributed to size and histology. In this study the investigators want to evaluate the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI) could be useful in the definition of the margins of the lesion before polypectomy.

Study Overview

• Status: Terminated
• Conditions: Polypectomy
• Intervention / Treatment: Device: NBI during polypectomy; Device: no NBI during polypectomy

Detailed Description

Interval colon cancers are an important clinical issue. Literature dealing with technics and quality of polypectomy is scarce. A recent paper from Pohl et al focused on non-pedunculated polyps of 5-20 mm, evaluating non complete polypectomy and factors related to it, revealing that 10% of these polyps were not completely resected. This fact was attributed to size and histology (the majority of non completely resected ones, were polyps of 10-20 mm and with serrated characteristics at the histology). In this study the investigators want to evaluate the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI) could be useful in the definition of the margins of the lesion before polypectomy.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Como, Italy, 22100
    • Valduce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Every polyp ≥ 5 mm and ≤ 20 mm

Exclusion Criteria:

• Inflammatory bowel Disease and/or International Normalized Ratio > 1.5

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NBI to perform the polipectomy; this arm will undergo polypectomy with the use of NBI to define the margins of the lesion	Device: NBI during polypectomy; NBI to perform the polipectomy
Experimental: no NBI to perform the polypectomy; this arm will undergo polipectomy without the use of NBI to define the margins of the lesion	Device: no NBI during polypectomy; no NBI to perform the polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
NBI efficacy in predicting radicality of polypectomy by taking random biopsies of margins after resection of the lesion	12 months

Collaborators and Investigators

• Sponsor: Valduce Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 854/2015