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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03243669
Enrollment
2146
Registered
2017-08-09
Start date
2010-12-01
Completion date
2014-12-31
Last updated
2023-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Adenoma

Keywords

Colonoscopy, High-definition endoscopy, Virtual chromoendoscopy, Adenoma detection rate (ADR)

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.

Interventions

DIAGNOSTIC_TESTHigh-definition

High-definition colonoscopy

Virtual chromoendoscopy

DIAGNOSTIC_TESTStandard

Standard colonoscopy

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adenoma detection rate (ADR)7-10 daysPercentage 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

MeasureTime frameDescription
Number of adenomas7-10 daysAdenoma per colonoscopy rate (APCR)
Type of adenomas7-10 daysSubtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026