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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Colonic Adenoma

Treatments: Diagnostic Test: Standard; Diagnostic Test: Virtual chromoendoscopy; Diagnostic Test: High-definition

Study type: Interventional

Funder types: Other

Identifiers

NCT03243669

S52580

Details and patient eligibility

About

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.

Enrollment: 2,146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,146 participants in 11 patient groups

Fujinon standard

Active Comparator group

Treatment:

Diagnostic Test: Standard

Fujinon HD

Active Comparator group

Description:

Fujinon high-definition

Treatment:

Diagnostic Test: High-definition

Fujinon HD + VC

Active Comparator group

Description:

Fujinon high-definition + virtual chromoendoscopy

Treatment:

Diagnostic Test: High-definition

Diagnostic Test: Virtual chromoendoscopy

Olympus standard

Active Comparator group

Treatment:

Diagnostic Test: Standard

Olympus HD

Active Comparator group

Description:

Olympus high-definition

Treatment:

Diagnostic Test: High-definition

Olympus VC

Active Comparator group

Description:

Olympus virtual chromoendoscopy

Treatment:

Diagnostic Test: Virtual chromoendoscopy

Olympus HD + VC

Active Comparator group

Description:

Olympus high-definition + virtual chromoendoscopy

Treatment:

Diagnostic Test: High-definition

Diagnostic Test: Virtual chromoendoscopy

Pentax standard

Active Comparator group

Treatment:

Diagnostic Test: Standard

Pentax HD

Active Comparator group

Description:

Pentax high-definition

Treatment:

Diagnostic Test: High-definition

Pentax VC

Active Comparator group

Description:

Pentax virtual chromoendoscopy

Treatment:

Diagnostic Test: Virtual chromoendoscopy

Pentax HD + VC

Active Comparator group

Description:

Pentax high-definition + virtual chromoendoscopy

Treatment:

Diagnostic Test: High-definition

Diagnostic Test: Virtual chromoendoscopy