Chromoendoscopy for Ulcerative Colitis Surveillance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Chiorean, Indiana University
ClinicalTrials.gov Identifier:
NCT00274209
First received: January 6, 2006
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.


Condition Intervention
Ulcerative Colitis
Crohn's Disease
Procedure: Chromoendoscopy with magnification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Prevalence of dysplastic lesions by white light vs. chromoendoscopy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

endoscopic biopsies


Enrollment: 100
Study Start Date: December 2005
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IBD patients at risk for neoplasia
Patients with long-standing ulcerative colitis or Crohn's colitis at risk for neoplasia.
Procedure: Chromoendoscopy with magnification
A blue dye (indigo carmine) will be sprayed prior to imaging the bowel lining using a zoom colonoscope. The dye is not absorbed and is safe for human use.

Detailed Description:

Patients with ulcerative colitis (UC) are at increased risk for colon cancer. Current guidelines recommend periodic surveillance colonoscopy in individuals who fulfill certain high-risk criteria. Endoscopists must perform a high number of biopsies (over 33 per patient) in order to increase the yield of such procedures. Chromoendoscopy (CE) has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. Whether CE can replace standard colonoscopy in the surveillance of patients with UC is unknown.

Comparison: both standard biopsies and targeted biopsies will be obtained during colonoscopy from patients with UC who are candidates for surveillance colonoscopy. The yield of the two methods will be compared based on the number of biopsies required to identify one dysplastic (precancerous) lesion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with ulcerative colitis satisfying criteria for surveillance colonoscopy

Criteria

Inclusion Criteria:

  • Ulcerative colitis, pancolitis > 8 years; left-sided > 15 years or
  • history of PSC or
  • history of previous dysplasia on colon biopsies or
  • family history of colon cancer in first degree relative

Exclusion Criteria:

  • any condition that precludes colonoscopy
  • expected survival less than 1 year
  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: NCT00274209

Locations
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Michael V Chiorean, MD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Michael Chiorean, Associate Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT00274209     History of Changes
Other Study ID Numbers: 0509-71
Study First Received: January 6, 2006
Last Updated: November 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Ulcerative colitis
Crohn's disease
Chromoendoscopy
Dysplasia
Neoplasia

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014