search
Back to results

Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study (NBI)

Primary Purpose

Colorectal Neoplasms, Colonic Polyps, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Olympus Colonoscope CFHQ190AL
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasms focused on measuring Colonoscopy, Diagnostic imaging, Colorectal Neoplasm, Tandem Colonoscopy, Flat Polyp, Nonpolypoid, Flat and Depressed Lesions, Primary Prevention, Endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients referred for routine colonoscopy are eligible

Exclusion Criteria:

  • Known Inflammatory bowel disease
  • Referred for endoscopic evaluation and removal of colorectal lesion
  • Personal or family history of polyposis or non-polyposis syndrome
  • Presentation for emergency endoscopy
  • Inability to remove polyp due to coagulopathy or thrombocytopenia
  • Inability to provide informed consent

Sites / Locations

  • Veterans Affairs Palo Alto
  • Veterans Affairs San Francisco
  • Veterans Affairs Kansas City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

High Definition NBI Colonoscopy

High Definition White Light Colonoscopy

Arm Description

Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.

Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.

Outcomes

Primary Outcome Measures

Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm
Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.

Secondary Outcome Measures

Percentage of Missed Lesions on Index Colonoscopy.
Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.
Percentage of Nonpolypoid (Flat) Missed Lesions
Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.

Full Information

First Posted
March 7, 2011
Last Updated
October 31, 2017
Sponsor
VA Palo Alto Health Care System
Collaborators
Kansas City Veteran Affairs Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01310699
Brief Title
Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study
Acronym
NBI
Official Title
Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
Collaborators
Kansas City Veteran Affairs Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high definition white light colonoscopy will detect an increased number of nonpolypoid (flat and depressed) colorectal neoplasm.
Detailed Description
Interval colorectal cancers diagnosed within a three year period following a clearing colonoscopy have been reported at a rate of 1 cancer/1000 person years.The majority of these cancers are likely a consequence of a missed neoplastic lesion during routine colonoscopy. Recent tandem colonoscopy studies have shown no significant difference in adenoma miss or detection rates using narrow band imaging as compared to colonoscopy using white light. However, higher detection of flat neoplastic lesions using NBI was shown in a meta-analysis and should be furthered studied, especially considering that they are thought to be a strong contributor to a false negative colonoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Colonic Polyps, Colorectal Cancer
Keywords
Colonoscopy, Diagnostic imaging, Colorectal Neoplasm, Tandem Colonoscopy, Flat Polyp, Nonpolypoid, Flat and Depressed Lesions, Primary Prevention, Endoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Definition NBI Colonoscopy
Arm Type
Experimental
Arm Description
Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
Arm Title
High Definition White Light Colonoscopy
Arm Type
Placebo Comparator
Arm Description
Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
Intervention Type
Device
Intervention Name(s)
Olympus Colonoscope CFHQ190AL
Intervention Description
Technically improved colonoscope with close focus high definition narrow band imaging.
Primary Outcome Measure Information:
Title
Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm
Description
Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.
Time Frame
One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
Secondary Outcome Measure Information:
Title
Percentage of Missed Lesions on Index Colonoscopy.
Description
Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.
Time Frame
One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
Title
Percentage of Nonpolypoid (Flat) Missed Lesions
Description
Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.
Time Frame
One week (time of procedure plus time for pathology of polyp to be analyzed by histology)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients referred for routine colonoscopy are eligible Exclusion Criteria: Known Inflammatory bowel disease Referred for endoscopic evaluation and removal of colorectal lesion Personal or family history of polyposis or non-polyposis syndrome Presentation for emergency endoscopy Inability to remove polyp due to coagulopathy or thrombocytopenia Inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tonya Kaltenbach, MD MS
Organizational Affiliation
San Francisco Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Veterans Affairs San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Veterans Affairs Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18319413
Citation
Soetikno RM, Kaltenbach T, Rouse RV, Park W, Maheshwari A, Sato T, Matsui S, Friedland S. Prevalence of nonpolypoid (flat and depressed) colorectal neoplasms in asymptomatic and symptomatic adults. JAMA. 2008 Mar 5;299(9):1027-35. doi: 10.1001/jama.299.9.1027.
Results Reference
background
PubMed Identifier
18523025
Citation
Kaltenbach T, Friedland S, Soetikno R. A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates. Gut. 2008 Oct;57(10):1406-12. doi: 10.1136/gut.2007.137984. Epub 2008 Jun 3.
Results Reference
background
PubMed Identifier
20656245
Citation
Kaltenbach T, Soetikno R. Image-enhanced endoscopy is critical in the detection, diagnosis, and treatment of non-polypoid colorectal neoplasms. Gastrointest Endosc Clin N Am. 2010 Jul;20(3):471-85. doi: 10.1016/j.giec.2010.04.001.
Results Reference
background
PubMed Identifier
11316211
Citation
Rex DK, Bond JH, Feld AD. Medical-legal risks of incident cancers after clearing colonoscopy. Am J Gastroenterol. 2001 Apr;96(4):952-7. doi: 10.1111/j.1572-0241.2001.03677.x.
Results Reference
background
PubMed Identifier
17631129
Citation
Rex DK, Helbig CC. High yields of small and flat adenomas with high-definition colonoscopes using either white light or narrow band imaging. Gastroenterology. 2007 Jul;133(1):42-7. doi: 10.1053/j.gastro.2007.04.029. Epub 2007 Apr 20.
Results Reference
background
PubMed Identifier
19111693
Citation
van den Broek FJ, Reitsma JB, Curvers WL, Fockens P, Dekker E. Systematic review of narrow-band imaging for the detection and differentiation of neoplastic and nonneoplastic lesions in the colon (with videos). Gastrointest Endosc. 2009 Jan;69(1):124-35. doi: 10.1016/j.gie.2008.09.040. No abstract available.
Results Reference
background
Links:
URL
http://www.nytimes.com/2008/03/05/health/research/05cancer.html
Description
Click here for more information about non-polypoid (flat and depressed) colorectal polyps:

Learn more about this trial

Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study

We'll reach out to this number within 24 hrs