High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps

January 26, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
Over the last years a number of new endoscopic imaging modalities have been introduced (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new imaging techniques, the investigators aimed to investigate their use for the detection of polyps during colonoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2146

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

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • referred for colonoscopy
  • signed informed consent

Exclusion Criteria:

  • subtotal colectomy
  • known colorectal tumor or polyp prior to colonoscopy
  • genetic predisposition to colon cancer namely FAP, HNPCC, Hyperplastic polyposis syndrome, juvenile polyposis, Peutz-Jeghers syndrome
  • inflammatory bowel disease
  • primary sclerosering cholangitis

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fujinon standard
Diagnostic test: Standard
Standard colonoscopy
Active Comparator: Fujinon HD
Fujinon high-definition
Diagnostic test: High-definition
High-definition colonoscopy
Active Comparator: Fujinon HD + VC
Fujinon high-definition + virtual chromoendoscopy
Diagnostic test: High-definition
High-definition colonoscopy
Diagnostic test: Virtual chromoendoscopy
Virtual chromoendoscopy
Active Comparator: Olympus standard
Diagnostic test: Standard
Standard colonoscopy
Active Comparator: Olympus HD
Olympus high-definition
Diagnostic test: High-definition
High-definition colonoscopy
Active Comparator: Olympus VC
Olympus virtual chromoendoscopy
Diagnostic test: Virtual chromoendoscopy
Virtual chromoendoscopy
Active Comparator: Olympus HD + VC
Olympus high-definition + virtual chromoendoscopy
Diagnostic test: High-definition
High-definition colonoscopy
Diagnostic test: Virtual chromoendoscopy
Virtual chromoendoscopy
Active Comparator: Pentax standard
Diagnostic test: Standard
Standard colonoscopy
Active Comparator: Pentax HD
Pentax high-definition
Diagnostic test: High-definition
High-definition colonoscopy
Active Comparator: Pentax VC
Pentax virtual chromoendoscopy
Diagnostic test: Virtual chromoendoscopy
Virtual chromoendoscopy
Active Comparator: Pentax HD + VC
Pentax high-definition + virtual chromoendoscopy
Diagnostic test: High-definition
High-definition colonoscopy
Diagnostic test: Virtual chromoendoscopy
Virtual chromoendoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate (ADR)
Time Frame: 7-10 days
Percentage of colonoscopies with detection of 1 or more adenomas. ADR is a well-established quality indicator in colonoscopy in the prevalence of adenomas detected (ADR) as recommended by American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology Task Force (ACGTF) and European Society of Gastrointestinal Endoscopy (ESGE). Guidelines stipulate to use ADR as main quality indicator in colonoscopy.
7-10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adenomas
Time Frame: 7-10 days
Adenoma per colonoscopy rate (APCR)
7-10 days
Type of adenomas
Time Frame: 7-10 days
Subtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas
7-10 days

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Raf Bisschops, MD PhD, Universitaire Ziekenhuizen KU Leuven

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 (Actual)

December 1, 2010

Primary Completion (Actual)

June 30, 2014

Study Completion (Actual)

December 31, 2014

Study Registration Dates

First Submitted

July 22, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (Actual)

August 9, 2017

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S52580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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