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Endoscopic Assessment of Polyp Histology

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Terminated
CT.gov ID
NCT01297712
Collaborator
(none)
1,069
Enrollment
1
Location
2
Arms
19
Duration (Months)
56.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Latest generation colonoscopy as diagnostic instrument
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1069 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
On-Site Endoscopic Prediction of Polyp Histology During Screening Colonoscopy
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Hi Line

This arm is examined with latest generation HDTV colonoscopes

Device: Latest generation colonoscopy as diagnostic instrument
this endoscope is used as compared to an older generations cope (classic line) currently in use
Other Names:
  • Hi Line colonoscopy
  • IScan Colonoscope

    		•
    No Intervention: Classic Line

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

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy (sensitivity/specificity) of HDTV/iScan image technology (Hi Line) versus conventional colonoscopy (classic Line) in the diagnosis of adenomas versus hyperplastic polyps [14 months]

    Secondary Outcome Measures

    1. Comparison of online accuracy during colonoscopy with later blinded image assessment in the differential diagnosis of adenomas versus hyperplastic polyps [14 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients undergoing screening colonoscopy
    Exclusion Criteria:

    • Missing consent

    • No screening colonoscopy (diagnostic colonoscopy because of symptoms)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Hamburg-Eppendorf Hamburg Germany 22453

    Sponsors and Collaborators

    • Universitätsklinikum Hamburg-Eppendorf

    Investigators

    • Principal Investigator: Thomas Rösch, MD, Universitätsklinikum Hamburg-Eppendorf

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Thomas Rösch, Director, Universitätsklinikum Hamburg-Eppendorf
    ClinicalTrials.gov Identifier:
    NCT01297712
    Other Study ID Numbers:
    • iScan study-1
    First Posted:
    Feb 17, 2011
    Last Update Posted:
    Jun 7, 2019
    Last Verified:
    Apr 1, 2019
    Keywords provided by Prof. Dr. Thomas Rösch, Director, Universitätsklinikum Hamburg-Eppendorf
    screening colonoscopy
    adenoma
    hyperplastic polyp
    differential diagnosis
    Additional relevant MeSH terms:
    Polyps
    Colonic Polyps

    Study Results

    No Results Posted as of Jun 7, 2019