Detection and Classification of Colon Polyps

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00825292
First received: December 26, 2007
Last updated: January 20, 2009
Last verified: January 2009
  Purpose

Colon cancer is the third most common cancer in western society. To prevent colon cancer it is recommended for people to undergo a screening colonoscopy at the age of fifty. The purpose of the colonoscopy is to remove polyps, since some of these lesions are precancerous. Precancerous polyps are called adenomas. This method of prevention is effective, but the standard colonoscopy currently used does not detect all polyps. Studies have reported a polyp miss rate of about 24%. Furthermore, we are unable to distinguish precancerous polyps from benign polyps, also known as hyperplastic polyps, with standard colonoscopy. This results in all polyps being removed at time of colonoscopy, even the benign polyps.

To help improve the detection of colon polyps new endoscopic technologies have been developed. These technologies include high definition white light (HDWL)and high definition narrow band imaging (HDNBI). HDWL improves the overall resolution of the images seen during colonoscopy. HDNBI can help us better classify polyps by enhancing their tissue appearance as well as seeing small blood vessels and capillaries.

The goal of this study to determine if HDNBI imaging shows an increased polyp detection rate when compared to the current standard colonoscopy. In addition to develop a classification system to help better differentiate between precancerous polyps and their benign counterparts using HDWL and HDNBI.


Condition Intervention Phase
Colon Polyps
Procedure: Polp removal and identification
Procedure: colon polyp removal
Procedure: ETMI colonoscope (ETMI scope is a FDA approved device)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Detection and Classification of Colon Polyps: A Comparison of High Definition White Light and Narrow Band Imaging (Endoscopic Trimodal Imaging; ETMI)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 1. Compare the miss rate of standard white light imaging compared to NBI for detection of colon polyps with NBI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 2. Estimate the accuracy of standard white light, HDWL and HDNBI imaging modes for the classification of adenomatous (premalignant) versus non-adenomatous (hyperplastic, inflammatory, normal) polyps. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: July 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
HDNBI colonoscopy followed by standard white light colonoscopy
Procedure: Polp removal and identification
Identify polyp during colonoscopy then remove polyp
Other Name: Colonoscopy with polypectomy
Procedure: ETMI colonoscope (ETMI scope is a FDA approved device)
ETMI colonoscope used to identify colon polyps as compared to HD white light colonoscope identifying colon polyps.
Other Name: Detecting and removing colon polyps
Active Comparator: 1
standard white light colonoscopy followed by HDNBI colonoscopy
Procedure: colon polyp removal
identify and remove polyp
Other Name: Colonoscopy with polypectomy
Procedure: ETMI colonoscope (ETMI scope is a FDA approved device)
ETMI colonoscope used to identify colon polyps as compared to HD white light colonoscope identifying colon polyps.
Other Name: Detecting and removing colon polyps

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 years or older.
  2. Informed written consent

Exclusion Criteria:

  1. History of inflammatory bowel disease.
  2. Patients with severe cardiopulmonary disease precluding colonoscopy.
  3. Presence of conditions not allowing for polypectomy or biopsy (e.g. coagulation disorder).
  4. Known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc)
  5. Sub-optimal preparation for the procedure, which will be determined by patient history or based on the initial colonoscopy.
  6. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825292

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Seth A. Gross, M.D. Mayo Clinic
Principal Investigator: Michael B. Wallace, M.D. Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Seth A. Gross, M.D. and Michael B. Wallace, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00825292     History of Changes
Other Study ID Numbers: 06-002653 00
Study First Received: December 26, 2007
Last Updated: January 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
colon polyps, colon adenomas

Additional relevant MeSH terms:
Colonic Polyps
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 21, 2014