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Endoscopic Assessment of Polyp Histology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01297712
Recruitment Status : Terminated (enrollment terminated, analysis ongoing)
First Posted : February 17, 2011
Last Update Posted : June 7, 2019
Information provided by (Responsible Party):
Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

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
Colonic Polyps Device: Latest generation colonoscopy as diagnostic instrument Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

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

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 [ Time Frame: 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 [ Time Frame: 14 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01297712

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University Hospital Hamburg-Eppendorf
Hamburg, Germany, 22453
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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Principal Investigator: Thomas Rösch, MD Universitätsklinikum Hamburg-Eppendorf
Publications of Results:
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Responsible Party: Prof. Dr. Thomas Rösch, Director, Universitätsklinikum Hamburg-Eppendorf Identifier: NCT01297712    
Other Study ID Numbers: iScan study-1
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: April 2019
Keywords provided by Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf:
screening colonoscopy
hyperplastic polyp
differential diagnosis
Additional relevant MeSH terms:
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Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps