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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00587236 |
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 |
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Colitis, Ulcerative Cholangitis, Sclerosing |
Study Type: | Observational |
Study Design: | Cohort, 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 |
Estimated Enrollment: | 65 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis.
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2
Patients with chronic ulcerative colitis and known dysplasia or cancer.
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary A Knipschield | 507-266-3972 | knipschield.mary@mayo.edu |
Contact: Debbra K Stark | 507-2661521 | stark.debbra@mayo.edu |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55902 | |
Contact: Diahann Seaman, MD 507-282-2511 seaman.diahann@mayo.edu | |
Principal Investigator: Christopher J Gostout, MD | |
Principal Investigator: Diahann Seaman, MD | |
Sub-Investigator: Keith D Lindor, MD | |
Sub-Investigator: William J Sandborn, MD | |
Sub-Investigator: Elizabeth Rajan, MD | |
Sub-Investigator: Kenneth W Schroeder, MD | |
Sub-Investigator: Edward V Loftus, MD | |
Sub-Investigator: Thomas C Smyrk, MD | |
Sub-Investigator: Louis M Wong Kee Song, MD | |
Sub-Investigator: Navtej S Buttar, MD |
Study Director: | Christopher J Gostout, MD | Mayo Clinic, Rochester, MN |
Responsible Party: | Principal Investigator, Mayo Clinic Rochester (MCR) ( Diahann Seaman, M.D. ) |
Study ID Numbers: | 5-06 |
Study First Received: | December 21, 2007 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00587236 |
Health Authority: | United States: Food and Drug Administration |
Autofluorescence Narrow Band High definition white light |
Primary sclerosing cholangitis Cholangitis, Sclerosing Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative |
Intestinal Diseases Cholangitis Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Gastroenteritis Colitis |
Pathologic Processes |