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OpenTrials
Completed

NCT Number: NCT03243669

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-definition

Diagnostic Test

High-definition colonoscopy

Virtual chromoendoscopy

Diagnostic Test

Virtual chromoendoscopy

Standard

Diagnostic Test

Standard colonoscopy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of adenomas

    Time frame: 7-10 days

    Adenoma per colonoscopy rate (APCR)

  2. Type of adenomas

    Time frame: 7-10 days

    Subtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 9, 2017
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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