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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02641509
Recruitment Status : Terminated
First Posted : December 29, 2015
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Alida Andrealli, Valduce Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Polypectomy Device: NBI during polypectomy Device: no NBI during polypectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Accuracy in Resection of Non-pedunculated Colonic Lesions 5-20 mm With/Without Using NBI
Study Start Date : January 2016
Actual Primary Completion Date : October 2019
Actual Study Completion Date : October 2019

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




Primary Outcome Measures :
  1. NBI efficacy in predicting radicality of polypectomy by taking random biopsies of margins after resection of the lesion [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Every polyp ≥ 5 mm and ≤ 20 mm

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641509


Locations
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Italy
Valduce Hospital
Como, Italy, 22100
Sponsors and Collaborators
Valduce Hospital
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Responsible Party: Alida Andrealli, MD, Valduce Hospital
ClinicalTrials.gov Identifier: NCT02641509    
Other Study ID Numbers: 854/2015
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020