Endoscopic Assessment of Polyp Histology

This study has been terminated.
(enrollment terminated, analysis ongoing)
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01297712
First received: February 14, 2011
Last updated: February 15, 2011
Last verified: February 2011
  Purpose

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 Intervention
Colonic Polyps
Device: Latest generation colonoscopy as diagnostic instrument

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: On-Site Endoscopic Prediction of Polyp Histology During Screening Colonoscopy

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

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 [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of online accuracy during colonoscopy with later blinded image assessment in the differential diagnosis of adenomas versus hyperplastic polyps [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Enrollment: 1069
Study Start Date: September 2009
Estimated Study Completion Date: April 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing screening colonoscopy

Exclusion Criteria:

  • Missing consent
  • No screening colonoscopy (diagnostic colonoscopy because of symptoms)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297712

Locations
Germany
University Hospital Hamburg-Eppendorf
Hamburg, Germany, 22453
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Thomas Rösch, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided by Universitätsklinikum Hamburg-Eppendorf

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ´Prof. Thomas Rösch, Principan Investigator, Department of Interdisciplinary Endoscopy, University Hospital Hamburg Eppendorf
ClinicalTrials.gov Identifier: NCT01297712     History of Changes
Other Study ID Numbers: iScan study-1
Study First Received: February 14, 2011
Last Updated: February 15, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
screening colonoscopy
adenoma
hyperplastic polyp
differential diagnosis

Additional relevant MeSH terms:
Colonic Polyps
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014