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Clinical Trials/NCT02876133
NCT02876133
Unknown
Not Applicable

Improving Colorectal Cancer Screening: Using Narrow Band Imaging for Colonic Sessile Serrated Lesions

Hospital Beatriz Ângelo3 sites in 1 country987 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colon Cancer
Sponsor
Hospital Beatriz Ângelo
Enrollment
987
Locations
3
Primary Endpoint
average number of serrated lesions ≥10 mm detected per colonoscopy
Last Updated
7 years ago

Overview

Brief Summary

Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.

Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
August 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alexandre Ferreira

Gastroenterologist

Hospital Beatriz Ângelo

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for elective colonoscopies

Exclusion Criteria

  • known polyposis syndromes
  • primary sclerosing cholangitis
  • inflammatory bowel disease
  • personal colorectal cancer history

Outcomes

Primary Outcomes

average number of serrated lesions ≥10 mm detected per colonoscopy

Time Frame: immediate

Secondary Outcomes

  • Serrated lesions <10 mm detected per colonoscopy(immediate)
  • Serrated class lesions detection rate(immediate)
  • Adenomas detected per colonoscopy(immediate)
  • SSL detection rate(immediate)
  • Adenoma detection rate(immediate)
  • Advanced (malignant) adenocarcinoma detection rate(immediate)
  • Incidence of procedure related adverse events(immediate)

Study Sites (3)

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