Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy

NCT ID: NCT00633620

Last Updated: 2008-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2007-10-31

Brief Summary

Narrow Band Imaging (NBI) with high-definition (HDTV) visualization has been implemented into GI endoscopy with the purpose to better highlight endoluminal pathological structures by improving their contrast. Previous studies from referral centers could not show significant differences in terms of colonoscopic adenoma detection rate, but either very high adenoma rates or some numerical differences suggested that some benefit may exist which may become evident with average adenoma rates and/or large case numbers.

In a prospective randomized trial performed exclusively in a multicenter private practice setting involving 6 examiners with substantial life-time experience (>10.000 colonoscopies) 1200 patients will undergo HDTV screening colonoscopy with either NBI or conventional imaging technique on instrument withdrawal. Primary outcome measure is the adenoma detection rate (ADR; i.e. number of adenomas per patient).

Detailed Description

in 5 private practices with 6 examiners, consecutive asymptomatic persons willing to undergo screening colonoscopy will be asked to participate in this randomized study.

After introduction of the colonoscope into the cecum, patients will be randomized into withdrawal with either the NBI mode or conventional imaging by using wide-angle colonoscopes with HDTV imaging (Olympus Corp., Hamburg, Germany) in both groups. Randomization lists will be used for group allocation in each individual practice. In the NBI group, switching back to conventional imaging, and the number of occasions for switching back and the reasons for it are documented in this group.

Patients bowel preparation consists mostly of polyethylene glycol lavage with 4-5 liters until clear rectal fluid is evacuated. All examiners shall take special care to wash and clean the entire large bowel during instrument introduction and withdrawal, in order to provide optimal imaging conditions.

The following parameters are documented:

• Age and sex of the patient
• Type and dosage of sedation
• Examination time, both for instrument introduction and withdrawal
• Polyp characteristics: size (measured by open forceps or snare), shape (pedunculated/elevated, sessile/flat, and location
• Polyp histology after removal using snare polypectomy or forceps removal (for polyps < 3 mm), or biopsy if there are contraindications
• Other lesions found such as cancers, diverticula, inflammatory lesions etc. The main outcome parameter is the adenoma detection rate (number of polyps/number of patients examined) in the two groups.

Secondary outcome measures include analysis of the total number of polyps, flat/sessile adenomas, small adenomas (< 1 cm), hyperplastic polyps with size determination and right-sided versus left-sided polyp location in both groups.

Conditions

Adenoma

Study Design

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

Study Groups

colonoscopy

Non-NBI HDTV colonoscopy

Group Type: EXPERIMENTAL

Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)

Intervention Type: DEVICE

colonoscopy withdrawal with NBI mode

Interventions

Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)

colonoscopy withdrawal with NBI mode

Intervention Type: DEVICE

Other Intervention Names

Olympus NBI colonoscope 180 HDTV

Eligibility Criteria

Inclusion Criteria

• Asymptomatic persons > 55 years willing to undergo screening colonoscopy

Exclusion Criteria

• Missing consent
• Symptomatic persons
• Poor general conditions, significant comorbidity

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Central Interdisciplinary Endoscopy Unit, Charité Berlin, CVK

Principal Investigators

Thomas Rösch, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charité Medical University Berlin

Locations

Charité University Hospitals, Campus Virchow Hospital

Berlin, State of Berlin, Germany

Countries

Germany

References

Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.

Reference Type: DERIVED

PMID: 22056301 (View on PubMed)

Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schroder A, Scheel M, Wiedenmann B, Rosch T. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial. Gastroenterology. 2009 Feb;136(2):410-6.e1; quiz 715. doi: 10.1053/j.gastro.2008.10.022. Epub 2008 Oct 15.

Reference Type: DERIVED

PMID: 19014944 (View on PubMed)

Other Identifiers

Berlin Colonoscopy Project 2

Identifier Type: -

Identifier Source: secondary_id

Charite-CVK-Endo-1

Identifier Type: -

Identifier Source: org_study_id