Endoscopic Assessment of Polyp Histology

NCT ID: NCT01297712

Last Updated: 2019-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1069 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-04-30

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.

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.

Conditions

Colonic Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Hi Line

This arm is examined with latest generation HDTV colonoscopes

Group Type: ACTIVE_COMPARATOR

Latest generation colonoscopy as diagnostic instrument

Intervention Type: DEVICE

this endoscope is used as compared to an older generations cope (classic line) currently in use

Classic Line

control group undergoing colonoscopy with older generation scope currently in use in most centers

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Latest generation colonoscopy as diagnostic instrument

this endoscope is used as compared to an older generations cope (classic line) currently in use

Intervention Type: DEVICE

Other Intervention Names

Hi Line colonoscopy; IScan Colonoscope

Eligibility Criteria

Inclusion Criteria

• All patients undergoing screening colonoscopy

Exclusion Criteria

• Missing consent
• No screening colonoscopy (diagnostic colonoscopy because of symptoms)

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Thomas Rösch

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Rösch, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

University Hospital Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

References

Schachschal G, Mayr M, Treszl A, Balzer K, Wegscheider K, Aschenbeck J, Aminalai A, Drossel R, Schroder A, Scheel M, Bothe CH, Bruhn JP, Burmeister W, Stange G, Bahr C, Kiesslich R, Rosch 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.

Reference Type: RESULT

PMID: 23812324 (View on PubMed)

Other Identifiers

iScan study-1

Identifier Type: -

Identifier Source: org_study_id