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Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection

Primary Purpose

Colon Cancer, Colon Sessile Serrated Adenoma/Polyp

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
narrow band imaging withdrawal
white light withdrawal
Sponsored by
Hospital Beatriz Ângelo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients scheduled for elective colonoscopies

Exclusion Criteria:

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

Sites / Locations

  • Hospital Beatriz ÂngeloRecruiting
  • Centro Hospitalar do Porto
  • Instituto Português de Oncologia do Porto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Narrow band imaging withdrawal

white light withdrawal

Arm Description

colonoscope withdrawal and mucosal inspection performed under narrow band imaging

colonoscope withdrawal and mucosal inspection performed under white light imaging

Outcomes

Primary Outcome Measures

average number of serrated lesions ≥10 mm detected per colonoscopy

Secondary Outcome Measures

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

Full Information

First Posted
August 18, 2016
Last Updated
September 25, 2018
Sponsor
Hospital Beatriz Ângelo
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1. Study Identification

Unique Protocol Identification Number
NCT02876133
Brief Title
Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection
Official Title
Improving Colorectal Cancer Screening: Using Narrow Band Imaging for Colonic Sessile Serrated Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Beatriz Ângelo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Colon Sessile Serrated Adenoma/Polyp

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
987 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Narrow band imaging withdrawal
Arm Type
Experimental
Arm Description
colonoscope withdrawal and mucosal inspection performed under narrow band imaging
Arm Title
white light withdrawal
Arm Type
Placebo Comparator
Arm Description
colonoscope withdrawal and mucosal inspection performed under white light imaging
Intervention Type
Device
Intervention Name(s)
narrow band imaging withdrawal
Intervention Description
colonoscope withdrawal and mucosal inspection performed under narrow band imaging
Intervention Type
Device
Intervention Name(s)
white light withdrawal
Intervention Description
colonoscope withdrawal and mucosal inspection performed under white light imaging
Primary Outcome Measure Information:
Title
average number of serrated lesions ≥10 mm detected per colonoscopy
Time Frame
immediate
Secondary Outcome Measure Information:
Title
Serrated class lesions detection rate
Description
number of patients with at least 1 lesion/total number of participants
Time Frame
immediate
Title
Serrated lesions <10 mm detected per colonoscopy
Time Frame
immediate
Title
SSL detection rate
Description
histologically defined according to the WHO criteria
Time Frame
immediate
Title
Adenoma detection rate
Description
number of patients with at least 1 adenoma/total number of participants
Time Frame
immediate
Title
Adenomas detected per colonoscopy
Time Frame
immediate
Title
Advanced (malignant) adenocarcinoma detection rate
Time Frame
immediate
Title
Incidence of procedure related adverse events
Time Frame
immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients scheduled for elective colonoscopies Exclusion Criteria: known polyposis syndromes primary sclerosing cholangitis inflammatory bowel disease personal colorectal cancer history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre O Ferreira, MD
Email
alex.gastrohep@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre O Ferreira, MD
Organizational Affiliation
Hospital Beatriz Ângelo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Beatriz Ângelo
City
Loures
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre O Ferreira, MD
Email
alex.gastrohep@gmail.com
First Name & Middle Initial & Last Name & Degree
Alexandre O Ferreira, MD
Facility Name
Centro Hospitalar do Porto
City
Porto
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo M Pinto, MD, PhD
Email
ricardomarcospinto@sapo.pt
First Name & Middle Initial & Last Name & Degree
Ricardo M Pinto, MD, PhD
Facility Name
Instituto Português de Oncologia do Porto
City
Porto
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario D Ribeiro, MD, PhD
Email
mdinisribeiro@gmail.com
First Name & Middle Initial & Last Name & Degree
Diogo Libânio, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22710576
Citation
Rex DK, Ahnen DJ, Baron JA, Batts KP, Burke CA, Burt RW, Goldblum JR, Guillem JG, Kahi CJ, Kalady MF, O'Brien MJ, Odze RD, Ogino S, Parry S, Snover DC, Torlakovic EE, Wise PE, Young J, Church J. Serrated lesions of the colorectum: review and recommendations from an expert panel. Am J Gastroenterol. 2012 Sep;107(9):1315-29; quiz 1314, 1330. doi: 10.1038/ajg.2012.161. Epub 2012 Jun 19.
Results Reference
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Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection

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