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

Valduce Hospital

Status: Terminated

Conditions: Polypectomy

Treatments: Device: no NBI during polypectomy; Device: NBI during polypectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02641509

854/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Every polyp ≥ 5 mm and ≤ 20 mm

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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113 participants in 2 patient groups

NBI to perform the polipectomy

Experimental group

Description:

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

Treatment:

Device: NBI during polypectomy

no NBI to perform the polypectomy

Experimental group

Description:

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

Treatment:

Device: no NBI during polypectomy