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

Not Applicable

Completed

• Conditions: Colonic Adenoma
• Interventions: Diagnostic Test: High-definition; Diagnostic Test: Standard; Diagnostic Test: Virtual chromoendoscopy

• Registration Number: NCT03243669
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-01
• Primary Completion: 2014-06-30
• Study Completion: 2014-12-31
• Study First Submitted: 2017-07-22
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-09
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olympus HD	High-definition	Olympus high-definition
Pentax HD	High-definition	Pentax high-definition
Olympus HD + VC	Virtual chromoendoscopy	Olympus high-definition + virtual chromoendoscopy
Pentax standard	Standard	-
Pentax VC	Virtual chromoendoscopy	Pentax virtual chromoendoscopy
Fujinon standard	Standard	-
Fujinon HD	High-definition	Fujinon high-definition
Fujinon HD + VC	High-definition	Fujinon high-definition + virtual chromoendoscopy
Olympus standard	Standard	-
Fujinon HD + VC	Virtual chromoendoscopy	Fujinon high-definition + virtual chromoendoscopy
Olympus VC	Virtual chromoendoscopy	Olympus virtual chromoendoscopy
Pentax HD + VC	High-definition	Pentax high-definition + virtual chromoendoscopy
Pentax HD + VC	Virtual chromoendoscopy	Pentax high-definition + virtual chromoendoscopy
Olympus HD + VC	High-definition	Olympus high-definition + virtual chromoendoscopy

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate (ADR)	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 Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium