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Endoscopic Assessment of Polyp Histology

This study has been terminated.
(enrollment terminated, analysis ongoing)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297712
First Posted: February 17, 2011
Last Update Posted: June 2, 2015
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.
Information provided by (Responsible Party):
Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
February 14, 2011
February 17, 2011
June 2, 2015
September 2009
November 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01297712 on ClinicalTrials.gov Archive Site
Comparison of online accuracy during colonoscopy with later blinded image assessment in the differential diagnosis of adenomas versus hyperplastic polyps [ Time Frame: 14 months ]
Same as current
Not Provided
Not Provided
 
Endoscopic Assessment of Polyp Histology
On-Site Endoscopic Prediction of Polyp Histology During Screening Colonoscopy
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Colonic Polyps
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
  • Active Comparator: Hi Line
    This arm is examined with latest generation HDTV colonoscopes
    Intervention: Device: Latest generation colonoscopy as diagnostic instrument
  • No Intervention: Classic Line
    control group undergoing colonoscopy with older generation scope currently in use in most centers
Schachschal G, Mayr M, Treszl A, Balzer K, Wegscheider K, Aschenbeck J, Aminalai A, Drossel R, Schröder A, Scheel M, Bothe CH, Bruhn JP, Burmeister W, Stange G, Bähr C, Kießlich R, Rösch 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1069
April 2011
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients undergoing screening colonoscopy

Exclusion Criteria:

  • Missing consent
  • No screening colonoscopy (diagnostic colonoscopy because of symptoms)
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01297712
iScan study-1
No
Not Provided
Not Provided
Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
Not Provided
Principal Investigator: Thomas Rösch, MD Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP