Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection

September 25, 2018 updated by: Alexandre Ferreira, Hospital Beatriz Ângelo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

987

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Loures, Portugal
        • Recruiting
        • Hospital Beatriz Ângelo
        • Contact:
        • Principal Investigator:
          • Alexandre O Ferreira, MD
      • Porto, Portugal
        • Not yet recruiting
        • Centro Hospitalar do Porto
        • Contact:
        • Principal Investigator:
          • Ricardo M Pinto, MD, PhD
      • Porto, Portugal
        • Not yet recruiting
        • Instituto Portugues de Oncologia do Porto
        • Contact:
        • Principal Investigator:
          • Diogo Libânio, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for elective colonoscopies

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Narrow band imaging withdrawal
colonoscope withdrawal and mucosal inspection performed under narrow band imaging
Device: narrow band imaging withdrawal
colonoscope withdrawal and mucosal inspection performed under narrow band imaging
Placebo Comparator: white light withdrawal
colonoscope withdrawal and mucosal inspection performed under white light imaging
Device: white light withdrawal
colonoscope withdrawal and mucosal inspection performed under white light imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
average number of serrated lesions ≥10 mm detected per colonoscopy
Time Frame: immediate
immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serrated class lesions detection rate
Time Frame: immediate
number of patients with at least 1 lesion/total number of participants
immediate
Serrated lesions <10 mm detected per colonoscopy
Time Frame: immediate
immediate
SSL detection rate
Time Frame: immediate
histologically defined according to the WHO criteria
immediate
Adenoma detection rate
Time Frame: immediate
number of patients with at least 1 adenoma/total number of participants
immediate
Adenomas detected per colonoscopy
Time Frame: immediate
immediate
Advanced (malignant) adenocarcinoma detection rate
Time Frame: immediate
immediate
Incidence of procedure related adverse events
Time Frame: immediate
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Beatriz Ângelo

Investigators

  • Principal Investigator: Alexandre O Ferreira, MD, Hospital Beatriz Ângelo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

September 26, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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