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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Polypectomy

Intervention / Treatment
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* Device: NBI during polypectomy
* Device: no NBI during polypectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Every polyp ≥ 5 mm and ≤ 20 mm Exclusion Criteria: Inflammatory bowel Disease and/or International Normalized Ratio > 1.5

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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