NCT03243669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
Last Updated

January 27, 2023

Status Verified

August 1, 2017

Enrollment Period

3.6 years

First QC Date

July 22, 2017

Last Update Submit

January 26, 2023

Conditions

Colonic Adenoma

Keywords

ColonoscopyHigh-definition endoscopyVirtual chromoendoscopyAdenoma detection rate (ADR)

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate (ADR)

    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.

    7-10 days

Secondary Outcomes (2)

  • Number of adenomas

    7-10 days

  • Type of adenomas

    7-10 days

Study Arms (11)

Fujinon standard

ACTIVE COMPARATOR
Diagnostic Test: Standard

Fujinon HD

ACTIVE COMPARATOR

Fujinon high-definition

Diagnostic Test: High-definition

Fujinon HD + VC

ACTIVE COMPARATOR

Fujinon high-definition + virtual chromoendoscopy

Diagnostic Test: High-definitionDiagnostic Test: Virtual chromoendoscopy

Olympus standard

ACTIVE COMPARATOR
Diagnostic Test: Standard

Olympus HD

ACTIVE COMPARATOR

Olympus high-definition

Diagnostic Test: High-definition

Olympus VC

ACTIVE COMPARATOR

Olympus virtual chromoendoscopy

Diagnostic Test: Virtual chromoendoscopy

Olympus HD + VC

ACTIVE COMPARATOR

Olympus high-definition + virtual chromoendoscopy

Diagnostic Test: High-definitionDiagnostic Test: Virtual chromoendoscopy

Pentax standard

ACTIVE COMPARATOR
Diagnostic Test: Standard

Pentax HD

ACTIVE COMPARATOR

Pentax high-definition

Diagnostic Test: High-definition

Pentax VC

ACTIVE COMPARATOR

Pentax virtual chromoendoscopy

Diagnostic Test: Virtual chromoendoscopy

Pentax HD + VC

ACTIVE COMPARATOR

Pentax high-definition + virtual chromoendoscopy

Diagnostic Test: High-definitionDiagnostic Test: Virtual chromoendoscopy

Interventions

High-definitionDIAGNOSTIC_TEST

High-definition colonoscopy

Fujinon HDFujinon HD + VCOlympus HDOlympus HD + VCPentax HDPentax HD + VC
Virtual chromoendoscopyDIAGNOSTIC_TEST

Virtual chromoendoscopy

Fujinon HD + VCOlympus HD + VCOlympus VCPentax HD + VCPentax VC
StandardDIAGNOSTIC_TEST

Standard colonoscopy

Fujinon standardOlympus standardPentax standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • referred for colonoscopy
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 25448873BACKGROUND

  • 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.

    PMID: 28268235BACKGROUND

Study Officials

  • Raf Bisschops, MD PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2017

First Posted

August 9, 2017

Study Start

December 1, 2010

Primary Completion

June 30, 2014

Study Completion

December 31, 2014

Last Updated

January 27, 2023

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)