NCT00614770

Brief Summary

In this study the investigators hypothesize that High Definition White Light colonoscopy and narrow band imaging (NBI) will detect a higher number of adenomas compared to standard definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp histology compared to high definition colonoscopy and standard colonoscopy. Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy, high-definition white light colonoscopy and NBI. Specific Aim 2 - To compare the number of adenoma detected per subject by standard colonoscopy, high-definition white light colonoscopy and NBI. Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface mucosal and vascular patterns during the procedure. Specific Aim 4 - To determine the inter-observer agreement between investigators for the recognition of various polyp patterns

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 17, 2010

Status Verified

June 1, 2010

Enrollment Period

1.8 years

First QC Date

January 31, 2008

Last Update Submit

June 16, 2010

Conditions

Adenomatous PolypNew Imaging Techniques in Colonoscopy

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (1)

  • The prevalence of adenomas in the three arms of the study.

    Number of subjects with adenomas in the three arms of the study

    2 years

Secondary Outcomes (1)

  • Secondary outcome will be number of adenomas detected per subject in the three arms, the sensitivity, specificity, and accuracy of predicting polyp histology real time by the three imaging modalities.

    2 years

Study Arms (3)

1

EXPERIMENTAL

Standard White Light Colonoscopy

Procedure: standard of care colonoscopy

2

EXPERIMENTAL

High Definition White Light Colonoscopy

Procedure: standard of care colonoscopy

3

EXPERIMENTAL

Narrow Band Imaging Colonoscopy

Procedure: colonoscopy

Interventions

standard of care colonoscopyPROCEDURE

Standard White Light Colonoscopy one exam per patient

1
colonoscopyPROCEDURE

Narrow Band Imaging Colonoscopy one exam per patient

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • referral for screening or surveillance colonoscopy
  • the ability to provide informed consent

You may not qualify if:

  • prior surgical resection of any portion of colon
  • prior history of colon cancer
  • history of inflammatory bowel disease
  • use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
  • poor general condition or any other reason to avoid prolonged procedure time
  • history of polyposis syndrome or HNPCC
  • inability to give informed consent.
  • Inadequate bowel preparation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Rastogi A, Early DS, Gupta N, Bansal A, Singh V, Ansstas M, Jonnalagadda SS, Hovis CE, Gaddam S, Wani SB, Edmundowicz SA, Sharma P. Randomized, controlled trial of standard-definition white-light, high-definition white-light, and narrow-band imaging colonoscopy for the detection of colon polyps and prediction of polyp histology. Gastrointest Endosc. 2011 Sep;74(3):593-602. doi: 10.1016/j.gie.2011.04.050. Epub 2011 Jul 29.

    PMID: 21802078DERIVED

MeSH Terms

Conditions

Adenomatous Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Amit Rastogi, MD

    Kansas City VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

February 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

June 17, 2010

Record last verified: 2010-06

Locations

US(2)