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

NCT ID: NCT03243669

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-01

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Colonic Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fujinon standard

Group Type ACTIVE_COMPARATOR

Standard

Intervention Type DIAGNOSTIC_TEST

Standard colonoscopy

Fujinon HD

Fujinon high-definition

Group Type ACTIVE_COMPARATOR

High-definition

Intervention Type DIAGNOSTIC_TEST

High-definition colonoscopy

Fujinon HD + VC

Fujinon high-definition + virtual chromoendoscopy

Group Type ACTIVE_COMPARATOR

High-definition

Intervention Type DIAGNOSTIC_TEST

High-definition colonoscopy

Virtual chromoendoscopy

Intervention Type DIAGNOSTIC_TEST

Virtual chromoendoscopy

Olympus standard

Group Type ACTIVE_COMPARATOR

Standard

Intervention Type DIAGNOSTIC_TEST

Standard colonoscopy

Olympus HD

Olympus high-definition

Group Type ACTIVE_COMPARATOR

High-definition

Intervention Type DIAGNOSTIC_TEST

High-definition colonoscopy

Olympus VC

Olympus virtual chromoendoscopy

Group Type ACTIVE_COMPARATOR

Virtual chromoendoscopy

Intervention Type DIAGNOSTIC_TEST

Virtual chromoendoscopy

Olympus HD + VC

Olympus high-definition + virtual chromoendoscopy

Group Type ACTIVE_COMPARATOR

High-definition

Intervention Type DIAGNOSTIC_TEST

High-definition colonoscopy

Virtual chromoendoscopy

Intervention Type DIAGNOSTIC_TEST

Virtual chromoendoscopy

Pentax standard

Group Type ACTIVE_COMPARATOR

Standard

Intervention Type DIAGNOSTIC_TEST

Standard colonoscopy

Pentax HD

Pentax high-definition

Group Type ACTIVE_COMPARATOR

High-definition

Intervention Type DIAGNOSTIC_TEST

High-definition colonoscopy

Pentax VC

Pentax virtual chromoendoscopy

Group Type ACTIVE_COMPARATOR

Virtual chromoendoscopy

Intervention Type DIAGNOSTIC_TEST

Virtual chromoendoscopy

Pentax HD + VC

Pentax high-definition + virtual chromoendoscopy

Group Type ACTIVE_COMPARATOR

High-definition

Intervention Type DIAGNOSTIC_TEST

High-definition colonoscopy

Virtual chromoendoscopy

Intervention Type DIAGNOSTIC_TEST

Virtual chromoendoscopy

Interventions

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High-definition

High-definition colonoscopy

Intervention Type DIAGNOSTIC_TEST

Virtual chromoendoscopy

Virtual chromoendoscopy

Intervention Type DIAGNOSTIC_TEST

Standard

Standard colonoscopy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raf Bisschops, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Am J Gastroenterol. 2015 Jan;110(1):72-90. doi: 10.1038/ajg.2014.385. Epub 2014 Dec 2. No abstract available.

Reference Type BACKGROUND
PMID: 25448873 (View on PubMed)

Kaminski MF, Thomas-Gibson S, Bugajski M, Bretthauer M, Rees CJ, Dekker E, Hoff G, Jover R, Suchanek S, Ferlitsch M, Anderson J, Roesch T, Hultcranz R, Racz I, Kuipers EJ, Garborg K, East JE, Rupinski M, Seip B, Bennett C, Senore C, Minozzi S, Bisschops R, Domagk D, Valori R, Spada C, Hassan C, Dinis-Ribeiro M, Rutter MD. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2017 Apr;49(4):378-397. doi: 10.1055/s-0043-103411. Epub 2017 Mar 7.

Reference Type BACKGROUND
PMID: 28268235 (View on PubMed)

Other Identifiers

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S52580

Identifier Type: -

Identifier Source: org_study_id

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