NCT00825292

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

2.4 years

First QC Date

December 26, 2007

Last Update Submit

January 20, 2009

Conditions

Colon Polyps

Keywords

colon polyps, colon adenomas

Outcome Measures

Primary Outcomes (1)

  • 1. Compare the miss rate of standard white light imaging compared to NBI for detection of colon polyps with NBI

    2 years

Secondary Outcomes (1)

  • 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.

    2 years

Study Arms (2)

2

ACTIVE COMPARATOR

HDNBI colonoscopy followed by standard white light colonoscopy

Procedure: Polp removal and identificationProcedure: ETMI colonoscope (ETMI scope is a FDA approved device)

1

ACTIVE COMPARATOR

standard white light colonoscopy followed by HDNBI colonoscopy

Procedure: colon polyp removalProcedure: ETMI colonoscope (ETMI scope is a FDA approved device)

Interventions

Polp removal and identificationPROCEDURE

Identify polyp during colonoscopy then remove polyp

Also known as: Colonoscopy with polypectomy
2
colon polyp removalPROCEDURE

identify and remove polyp

Also known as: Colonoscopy with polypectomy
1
ETMI colonoscope (ETMI scope is a FDA approved device)PROCEDURE

ETMI colonoscope used to identify colon polyps as compared to HD white light colonoscope identifying colon polyps.

Also known as: Detecting and removing colon polyps
12

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older.
  • Informed written consent

You may not qualify if:

  • History of inflammatory bowel disease.
  • Patients with severe cardiopulmonary disease precluding colonoscopy.
  • Presence of conditions not allowing for polypectomy or biopsy (e.g. coagulation disorder).
  • Known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc)
  • Sub-optimal preparation for the procedure, which will be determined by patient history or based on the initial colonoscopy.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Publications (8)

  • Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8.

    PMID: 14974761BACKGROUND

  • Morson BC. Precancerous and early malignant lesions of the large intestine. Br J Surg. 1968 Oct;55(10):725-31. doi: 10.1002/bjs.1800551003. No abstract available.

    PMID: 5681027BACKGROUND

  • Morson B. President's address. The polyp-cancer sequence in the large bowel. Proc R Soc Med. 1974 Jun;67(6 Pt 1):451-7. doi: 10.1177/00359157740676P115. No abstract available.

    PMID: 4853754BACKGROUND

  • Cappell MS, Forde KA. Spatial clustering of multiple hyperplastic, adenomatous, and malignant colonic polyps in individual patients. Dis Colon Rectum. 1989 Aug;32(8):641-52. doi: 10.1007/BF02555767.

    PMID: 2752850BACKGROUND

  • Rex DK, Chadalawada V, Helper DJ. Wide angle colonoscopy with a prototype instrument: impact on miss rates and efficiency as determined by back-to-back colonoscopies. Am J Gastroenterol. 2003 Sep;98(9):2000-5. doi: 10.1111/j.1572-0241.2003.07662.x.

    PMID: 14499778BACKGROUND

  • Muto M, Katada C, Sano Y, Yoshida S. Narrow band imaging: a new diagnostic approach to visualize angiogenesis in superficial neoplasia. Clin Gastroenterol Hepatol. 2005 Jul;3(7 Suppl 1):S16-20. doi: 10.1016/s1542-3565(05)00262-4.

    PMID: 16012987BACKGROUND

  • Kara MA, Peters FP, Rosmolen WD, Krishnadath KK, ten Kate FJ, Fockens P, Bergman JJ. High-resolution endoscopy plus chromoendoscopy or narrow-band imaging in Barrett's esophagus: a prospective randomized crossover study. Endoscopy. 2005 Oct;37(10):929-36. doi: 10.1055/s-2005-870433.

    PMID: 16189764BACKGROUND

  • Gross SA, Buchner AM, Crook JE, Cangemi JR, Picco MF, Wolfsen HC, DeVault KR, Loeb DS, Raimondo M, Woodward TA, Wallace MB. A comparison of high definition-image enhanced colonoscopy and standard white-light colonoscopy for colorectal polyp detection. Endoscopy. 2011 Dec;43(12):1045-51. doi: 10.1055/s-0030-1256894. Epub 2011 Oct 4.

    PMID: 21971929DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

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

  • Seth A. Gross, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Michael B. Wallace, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 21, 2009

Study Start

July 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 21, 2009

Record last verified: 2009-01

Locations

US(1)