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

Polypectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02641509
• Other study ID #: 854/2015
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 2019

Study information

• Verified date: May 2020
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 113
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Every polyp = 5 mm and = 20 mm

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Polypectomy

Intervention

Device:
• NBI during polypectomy
NBI to perform the polipectomy
• no NBI during polypectomy
no NBI to perform the polypectomy

Locations

Country	Name	City	State
Italy	Valduce Hospital	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NBI efficacy in predicting radicality of polypectomy by taking random biopsies of margins after resection of the lesion		12 months