Accuracy in Resection of Non-pedunculated Colonic Lesions 5-20 mm With/Without Using NBI
1 other identifier
interventional
113
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2015
CompletedFirst Posted
Study publicly available on registry
December 29, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedMay 21, 2020
May 1, 2020
3.8 years
November 30, 2015
May 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
NBI efficacy in predicting radicality of polypectomy by taking random biopsies of margins after resection of the lesion
12 months
Study Arms (2)
NBI to perform the polipectomy
EXPERIMENTALthis arm will undergo polypectomy with the use of NBI to define the margins of the lesion
no NBI to perform the polypectomy
EXPERIMENTALthis arm will undergo polipectomy without the use of NBI to define the margins of the lesion
Interventions
Eligibility Criteria
You may qualify if:
- Every polyp ≥ 5 mm and ≤ 20 mm
You may not qualify if:
- Inflammatory bowel Disease and/or International Normalized Ratio \> 1.5
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Valduce Hospitallead
Study Sites (1)
Valduce Hospital
Como, 22100, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 30, 2015
First Posted
December 29, 2015
Study Start
January 1, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
May 21, 2020
Record last verified: 2020-05