Endoscopic Assessment of Polyp Histology

Colonic Polyps Clinical Trial

Official title:

On-Site Endoscopic Prediction of Polyp Histology During Screening Colonoscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01297712
• Other study ID #: iScan study-1
• Status: Terminated
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps

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