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

Primary Purpose

Colonic Adenoma

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

High-definition

Virtual chromoendoscopy

Standard

About this trial

This is an interventional diagnostic trial for Colonic Adenoma focused on measuring Colonoscopy, High-definition endoscopy, Virtual chromoendoscopy, Adenoma detection rate (ADR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Active Comparator

Arm Label

Fujinon standard

Fujinon HD

Fujinon HD + VC

Olympus standard

Olympus HD

Olympus VC

Olympus HD + VC

Pentax standard

Pentax HD

Pentax VC

Pentax HD + VC

Arm Description

Fujinon high-definition

Fujinon high-definition + virtual chromoendoscopy

Olympus high-definition

Olympus virtual chromoendoscopy

Olympus high-definition + virtual chromoendoscopy

Pentax high-definition

Pentax virtual chromoendoscopy

Pentax high-definition + virtual chromoendoscopy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of adenomas

Adenoma per colonoscopy rate (APCR)

Type of adenomas

Subtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas

Full Information

NCT ID

NCT03243669

First Posted

July 22, 2017

Last Updated

January 26, 2023

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT03243669

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

December 1, 2010 (Actual)

Primary Completion Date

June 30, 2014 (Actual)

Study Completion Date

December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Adenoma

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2146 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fujinon standard

Arm Type

Active Comparator

Arm Title

Fujinon HD

Arm Type

Active Comparator

Arm Description

Fujinon high-definition

Arm Title

Fujinon HD + VC

Arm Type

Active Comparator

Arm Description

Fujinon high-definition + virtual chromoendoscopy

Arm Title

Olympus standard

Arm Type

Active Comparator

Arm Title

Olympus HD

Arm Type

Active Comparator

Arm Description

Olympus high-definition

Arm Title

Olympus VC

Arm Type

Active Comparator

Arm Description

Olympus virtual chromoendoscopy

Arm Title

Olympus HD + VC

Arm Type

Active Comparator

Arm Description

Olympus high-definition + virtual chromoendoscopy

Arm Title

Pentax standard

Arm Type

Active Comparator

Arm Title

Pentax HD

Arm Type

Active Comparator

Arm Description

Pentax high-definition

Arm Title

Pentax VC

Arm Type

Active Comparator

Arm Description

Pentax virtual chromoendoscopy

Arm Title

Pentax HD + VC

Arm Type

Active Comparator

Arm Description

Pentax high-definition + virtual chromoendoscopy

Intervention Type

Diagnostic Test

Intervention Name(s)

High-definition

Intervention Description

High-definition colonoscopy

Intervention Type

Diagnostic Test

Intervention Name(s)

Virtual chromoendoscopy

Intervention Description

Virtual chromoendoscopy

Intervention Type

Diagnostic Test

Intervention Name(s)

Standard

Intervention Description

Standard colonoscopy

Primary Outcome Measure Information:

Title

Adenoma detection rate (ADR)

Description

Time Frame

7-10 days

Secondary Outcome Measure Information:

Title

Number of adenomas

Description

Adenoma per colonoscopy rate (APCR)

Time Frame

7-10 days

Title

Type of adenomas

Description

Subtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas

Time Frame

7-10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raf Bisschops, MD PhD

Organizational Affiliation

Universitaire Ziekenhuizen KU Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25448873

Citation

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.

Results Reference

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PubMed Identifier

28268235

Citation

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.

Results Reference

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

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