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Endoscopic Assessment of Polyp Histology

Primary Purpose

Colonic Polyps

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Latest generation colonoscopy as diagnostic instrument
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyps focused on measuring screening colonoscopy, adenoma, hyperplastic polyp, differential diagnosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients undergoing screening colonoscopy

Exclusion Criteria:

  • Missing consent
  • No screening colonoscopy (diagnostic colonoscopy because of symptoms)

Sites / Locations

  • University Hospital Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Hi Line

Classic Line

Arm Description

This arm is examined with latest generation HDTV colonoscopes

control group undergoing colonoscopy with older generation scope currently in use in most centers

Outcomes

Primary Outcome Measures

Accuracy (sensitivity/specificity) of HDTV/iScan image technology (Hi Line) versus conventional colonoscopy (classic Line) in the diagnosis of adenomas versus hyperplastic polyps

Secondary Outcome Measures

Comparison of online accuracy during colonoscopy with later blinded image assessment in the differential diagnosis of adenomas versus hyperplastic polyps

Full Information

First Posted
February 14, 2011
Last Updated
June 5, 2019
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT01297712
Brief Title
Endoscopic Assessment of Polyp Histology
Official Title
On-Site Endoscopic Prediction of Polyp Histology During Screening Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
enrollment terminated, analysis ongoing
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Polyps found during screening colonoscopy have to be removed or at least biopsied. Attempts to save costs include endoscopic assessment of polyps with regards to differential diagnoses between adenomas (which have to be removed) and hyperplastic polyps (could be left in place or removed and not examined histologically). Such a concept would only be feasible if endoscopy can make the differential diagnosis with high accuracy. Such high accuracy rates - between 80% and 95% - have been reported from reference centers with specific scientific interest. The investigators want to test whether these results a) can be reproduced in the private practice setting performing large-volume screening colonoscopies and b) whether latest generation endoscopes provide benefit in terms of better accuracy.
Detailed Description
Patients undergoing screening colonoscopy will be randomized to the use of two different colonoscopes, namely the latest generation (Pentax iScan, Hi Line) versus the previous generation (Classic Line). On withdrawal, all polyps found will be diagnosed according to their pit pattern (classification scheme mit example images provided) and a differential diagnosis made during the live examination. Pit patterns I/II will be classified as hyperplastic polyps, patterns III-V as adenomas (in a subgroup IV and V will be classified as pre-/malignant). All polyps will be photographed from near distance to allow for later blinded review which will be done on patients with only one polyp (to avoid mix-up of polyps) by 3 examiners and 2 independent hospital experts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
Keywords
screening colonoscopy, adenoma, hyperplastic polyp, differential diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1069 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hi Line
Arm Type
Active Comparator
Arm Description
This arm is examined with latest generation HDTV colonoscopes
Arm Title
Classic Line
Arm Type
No Intervention
Arm Description
control group undergoing colonoscopy with older generation scope currently in use in most centers
Intervention Type
Device
Intervention Name(s)
Latest generation colonoscopy as diagnostic instrument
Other Intervention Name(s)
Hi Line colonoscopy, IScan Colonoscope
Intervention Description
this endoscope is used as compared to an older generations cope (classic line) currently in use
Primary Outcome Measure Information:
Title
Accuracy (sensitivity/specificity) of HDTV/iScan image technology (Hi Line) versus conventional colonoscopy (classic Line) in the diagnosis of adenomas versus hyperplastic polyps
Time Frame
14 months
Secondary Outcome Measure Information:
Title
Comparison of online accuracy during colonoscopy with later blinded image assessment in the differential diagnosis of adenomas versus hyperplastic polyps
Time Frame
14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients undergoing screening colonoscopy Exclusion Criteria: Missing consent No screening colonoscopy (diagnostic colonoscopy because of symptoms)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Rösch, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
22453
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23812324
Citation
Schachschal G, Mayr M, Treszl A, Balzer K, Wegscheider K, Aschenbeck J, Aminalai A, Drossel R, Schroder A, Scheel M, Bothe CH, Bruhn JP, Burmeister W, Stange G, Bahr C, Kiesslich R, Rosch T. Endoscopic versus histological characterisation of polyps during screening colonoscopy. Gut. 2014 Mar;63(3):458-65. doi: 10.1136/gutjnl-2013-304562. Epub 2013 Jun 28.
Results Reference
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Endoscopic Assessment of Polyp Histology

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