ClinicalTrials.gg
TerminatedNCT02641509Updated May 21, 2020

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

An interventional study of NBI during polypectomy and no NBI during polypectomy in Polypectomy, sponsored by Valduce Hospital. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-21.

Sponsored by Valduce Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Polypectomy
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In context

Lead sponsor

Valduce Hospital is the lead sponsor of 29 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Every polyp ≥ 5 mm and ≤ 20 mm

Exclusion criteria

Exclusion Criteria:

  • Inflammatory bowel Disease and/or > 1.5
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
113 participants (actual)

Study arms

  • Experimental
    NBI to perform the polipectomy

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

    Device: NBI during polypectomy

  • Experimental
    no NBI to perform the polypectomy

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

    Device: no NBI during polypectomy

Interventions

  • DeviceNBI during polypectomy

    NBI to perform the polipectomy

  • Deviceno NBI during polypectomy

    no NBI to perform the polypectomy

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What researchers measure

Primary outcomes

  1. NBI efficacy in predicting radicality of polypectomy by taking random biopsies of margins after resection of the lesion

    Time frame: 12 months

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Study locations

1 site
  • Valduce Hospital
    Como, 22100, Italy
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02641509
Lead sponsor
Valduce Hospital
Responsible party
Alida Andrealli (MD, Valduce Hospital) — Principal investigator
First posted
Dec 29, 2015
Start date
Jan 2016
Primary completion
Oct 2019
Completion
Oct 2019
Last update
May 21, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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