Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587236
First received: December 21, 2007
Last updated: August 6, 2010
Last verified: August 2010
  Purpose

This study is being done to:

To attempt to increase the detection of precancerous colon tissue in patients with chronic ulcerative colitis and primary sclerosing cholangitis;

To determine if an investigational scope that can look at the lining of the colon in different ways will help the doctor identify abnormal tissue in patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis; and

To determine if this investigational scope can accurately detect precancerous or cancerous tissue in patients with chronic ulcerative colitis that are known to have had cancerous or precancerous tissue in the past.


Condition
Colitis, Ulcerative
Cholangitis, Sclerosing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Blinded Comparison of Conventional Colonoscopy to Endoscopic AFI and NBI for Dysplasia Detection in Patients With Ulcerative Colitis and Sclerosing Cholangitis or Known Colorectal Dysplasia or Cancer- A Pilot Clinical Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Compare the dysplasia detection rate between scope modalities and biopsy type; surveillance or targeted biopsies in CUC patients with concurrent PSC. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the impact of patient related factors on the difference in dysplasia detection rate between while light colonoscopy and the AFI and NBI techniques in patients with CUC and concurrent PSC. [ Time Frame: Two years. ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: March 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis.
2
Patients with chronic ulcerative colitis and known dysplasia or cancer.

Detailed Description:

Patients with concurrent chronic ulcerative colitis and primary sclerosing cholangitis or patients with chronic ulcerative colitis and known colorectal dysplasia or cancer, presenting for surveillance colonoscopy will be recruited. After giving informed consent patients will then undergo colonoscopy in a segmental fashion. Colonoscopy with white light will be performed to the cecum and examination will be performed on withdrawal. First conventional white light will be used to examine the cecum and ascending colon and random biopsies will be obtained. All endoscopically apparent lesions will be biopsied separately. Immediately following will be examination of that segment of cecum and ascending colon under AFI first, then NBI with targeted biopsies of suspicious areas being taken. The AFI and NBI modality will be achieved by simply flipping a switch.. If necessary, washing of oozing blood from random biopsy sites will be performed., The remainder of the colon will be assessed in like fashion: transverse, descending and rectosigmoid. Because high definition endoscopy is the default modality, this will be in use throughout the procedure.

All lesions detected will be documented and biopsied for a maximum of four biopsies per suspicious lesion. Note will be taken of which modality resulted in visualization of the lesion. Data on the factors under study will be collected: i) disease type (CUC + PSC or CUC with known dysplasia), ii) Age, iii) Sex, iv) length of time with disease, v) extent of disease, vi) the interaction between iv and v will be collected. In addition, dysplasia yes/no will be established after biopsy histology is established and the modality under which abnormalities were observed will also be recorded.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting with chronic ulcerative colitis and Primary sclerosing cholangitis and/or patients with chronic ulcerative colitis and known colorectal dysplasia or cancer needing a surveillance colonoscopy.

Criteria

Inclusion Criteria:

  • patients requiring a clinically indicated surveillance colonoscopy
  • able to give informed written consent
  • history of chronic ulcerative colitis and colonic dysplasia/or cancer or primary sclerosing cholangitis

Exclusion Criteria:

  • patients with known colonic obstruction
  • INR ./= 2.5 or thrombocytopenia ,50,000
  • patients with clinically important cardiopulmonary disease who are unable to safely undergo prolonged conscious sedation
  • pregnancy
  • symptomatic coronary artery disease
  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: NCT00587236

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Director: Christopher J Gostout, MD Mayo Clinic, Rochester, MN
  More Information

Additional Information:
Publications:

Responsible Party: Christopher J. Gostout, M.D., Principal Investigator, Mayo Clinic Rochester (MCR)
ClinicalTrials.gov Identifier: NCT00587236     History of Changes
Other Study ID Numbers: 5-06
Study First Received: December 21, 2007
Last Updated: August 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Autofluorescence
Narrow Band
High definition white light

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Colitis
Colitis, Ulcerative
Ulcer
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014