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Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis
This study is currently recruiting participants.
Verified by Mayo Clinic, May 2008
Sponsored by: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587236
  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

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Endoscopy Ulcerative Colitis
U.S. FDA Resources
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

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587236

Contacts
Contact: Mary A Knipschield 507-266-3972 knipschield.mary@mayo.edu
Contact: Debbra K Stark 507-2661521 stark.debbra@mayo.edu

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

Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

Publications:
Eaden JA, Abrams KR, Mayberry JF. The risk of colorectal cancer in ulcerative colitis: a meta-analysis. Gut. 2001 Apr;48(4):526-35.
Provenzale D, Onken J. Surveillance issues in inflammatory bowel disease: ulcerative colitis. J Clin Gastroenterol. 2001 Feb;32(2):99-105.
Rubin CE, Haggitt RC, Burmer GC, Brentnall TA, Stevens AC, Levine DS, Dean PJ, Kimmey M, Perera DR, Rabinovitch PS. DNA aneuploidy in colonic biopsies predicts future development of dysplasia in ulcerative colitis. Gastroenterology. 1992 Nov;103(5):1611-20.
Taylor BA, Pemberton JH, Carpenter HA, Levin KE, Schroeder KW, Welling DR, Spencer MP, Zinsmeister AR. Dysplasia in chronic ulcerative colitis: implications for colonoscopic surveillance. Dis Colon Rectum. 1992 Oct;35(10):950-6.
Rembacken BJ, Fujii T, Cairns A, Dixon MF, Yoshida S, Chalmers DM, Axon AT. Flat and depressed colonic neoplasms: a prospective study of 1000 colonoscopies in the UK. Lancet. 2000 Apr 8;355(9211):1211-4.
Kudo S, Tamura S, Nakajima T, Yamano H, Kusaka H, Watanabe H. Diagnosis of colorectal tumorous lesions by magnifying endoscopy. Gastrointest Endosc. 1996 Jul;44(1):8-14.
Kiesslich R, Fritsch J, Holtmann M, Koehler HH, Stolte M, Kanzler S, Nafe B, Jung M, Galle PR, Neurath MF. Methylene blue-aided chromoendoscopy for the detection of intraepithelial neoplasia and colon cancer in ulcerative colitis. Gastroenterology. 2003 Apr;124(4):880-8.
Rutter MD, Saunders BP, Schofield G, Forbes A, Price AB, Talbot IC. Pancolonic indigo carmine dye spraying for the detection of dysplasia in ulcerative colitis. Gut. 2004 Feb;53(2):256-60.
Kara MA, Peters FP, Ten Kate FJ, Van Deventer SJ, Fockens P, Bergman JJ. Endoscopic video autofluorescence imaging may improve the detection of early neoplasia in patients with Barrett's esophagus. Gastrointest Endosc. 2005 May;61(6):679-85.
Haringsma J, Tytgat GN. The value of fluorescence techniques in gastrointestinal endoscopy: better than the endoscopist's eye? I: The European experience. Endoscopy. 1998 May;30(4):416-8. Review. No abstract available.
Nakayoshi T, Tajiri H, Matsuda K, Kaise M, Ikegami M, Sasaki H. Magnifying endoscopy combined with narrow band imaging system for early gastric cancer: correlation of vascular pattern with histopathology (including video). Endoscopy. 2004 Dec;36(12):1080-4.
Hamamoto Y, Endo T, Nosho K, Arimura Y, Sato M, Imai K. Usefulness of narrow-band imaging endoscopy for diagnosis of Barrett's esophagus. J Gastroenterol. 2004 Jan;39(1):14-20.
Machida H, Sano Y, Hamamoto Y, Muto M, Kozu T, Tajiri H, Yoshida S. Narrow-band imaging in the diagnosis of colorectal mucosal lesions: a pilot study. Endoscopy. 2004 Dec;36(12):1094-8.
Riddell RH, Goldman H, Ransohoff DF, Appelman HD, Fenoglio CM, Haggitt RC, Ahren C, Correa P, Hamilton SR, Morson BC, et al. Dysplasia in inflammatory bowel disease: standardized classification with provisional clinical applications. Hum Pathol. 1983 Nov;14(11):931-68.

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

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009