Endoscopic Assessment of Polyp Histology

NCT01297712 | Terminated

• 1 other identifier: iScan study-1
• Study Type: interventional
• Target: 1,069
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyps

Keywords

screening colonoscopy; adenoma; hyperplastic polyp; differential diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of online accuracy during colonoscopy with later blinded image assessment in the differential diagnosis of adenomas versus hyperplastic polyps

  14 months

Study Arms (2)

Hi Line

ACTIVE COMPARATOR

This arm is examined with latest generation HDTV colonoscopes

Device: Latest generation colonoscopy as diagnostic instrument

Classic Line

NO INTERVENTION

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

Interventions

Latest generation colonoscopy as diagnostic instrument DEVICE

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

Also known as: Hi Line colonoscopy, IScan Colonoscope

Hi Line

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing screening colonoscopy

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, 22453, Germany

Location

Related Publications (1)

• 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.

  PMID: 23812324 RESULT

MeSH Terms

Conditions

Colonic Polyps; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Thomas Rösch, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 17, 2011
• Study Start: September 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: April 1, 2011
• Last Updated: June 7, 2019

Record last verified: 2019-04

Locations

DE (1)