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

NCT ID: NCT02641509

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-10-31

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.

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.

Conditions

Polypectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NBI to perform the polipectomy

this arm will undergo polypectomy with the use of NBI to define the margins of the lesion

Group Type: EXPERIMENTAL

NBI during polypectomy

Intervention Type: DEVICE

NBI to perform the polipectomy

no NBI to perform the polypectomy

this arm will undergo polipectomy without the use of NBI to define the margins of the lesion

Group Type: EXPERIMENTAL

no NBI during polypectomy

Intervention Type: DEVICE

no NBI to perform the polypectomy

Interventions

NBI during polypectomy

NBI to perform the polipectomy

Intervention Type: DEVICE

no NBI during polypectomy

no NBI to perform the polypectomy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Every polyp ≥ 5 mm and ≤ 20 mm

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valduce Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alida Andrealli

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Valduce Hospital

Como, , Italy

Countries

Italy

Other Identifiers

854/2015

Identifier Type: -

Identifier Source: org_study_id