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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01297712
Other study ID # iScan study-1
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2009
Est. completion date April 2011

Study information

Verified date April 2019
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1069
Est. completion date April 2011
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria:

- All patients undergoing screening colonoscopy

Exclusion Criteria:

- Missing consent

- No screening colonoscopy (diagnostic colonoscopy because of symptoms)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Latest generation colonoscopy as diagnostic instrument
this endoscope is used as compared to an older generations cope (classic line) currently in use

Locations

Country Name City State
Germany University Hospital Hamburg-Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Comparison of online accuracy during colonoscopy with later blinded image assessment in the differential diagnosis of adenomas versus hyperplastic polyps 14 months
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