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

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ClinicalTrials.gov Identifier: NCT00587236
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Christopher J. Gostout, Mayo Clinic

Tracking Information
First Submitted Date December 21, 2007
First Posted Date January 7, 2008
Last Update Posted Date January 14, 2016
Study Start Date March 2006
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2007)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00587236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 21, 2007)
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. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis
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
Brief Summary

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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Colitis, Ulcerative
  • Cholangitis, Sclerosing
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis.
  • 2
    Patients with chronic ulcerative colitis and known dysplasia or cancer.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 21, 2007)
65
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00587236
Other Study ID Numbers 5-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christopher J. Gostout, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Study Director: Christopher J Gostout, MD Mayo Clinic, Rochester, MN
PRS Account Mayo Clinic
Verification Date January 2016