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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02641509
Enrollment
113
Registered
2015-12-29
Start date
2016-01-31
Completion date
2019-10-31
Last updated
2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polypectomy

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.

Interventions

DEVICENBI during polypectomy

NBI to perform the polipectomy

DEVICEno NBI during polypectomy

no NBI to perform the polypectomy

Sponsors

Valduce Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Every polyp ≥ 5 mm and ≤ 20 mm

Exclusion criteria

* Inflammatory bowel Disease and/or International Normalized Ratio \> 1.5

Design outcomes

Primary

MeasureTime frame
NBI efficacy in predicting radicality of polypectomy by taking random biopsies of margins after resection of the lesion12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026