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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


N/A
18 Years
75 Years
Not Enrolling
Both
Colitis, Ulcerative, Cholangitis, Sclerosing

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Compare the dysplasia detection rate between scope modalities and biopsy type; surveillance or targeted biopsies in CUC patients with concurrent PSC.

Outcome Time Frame:

Two years

Safety Issue:

Yes

Principal Investigator

Christopher J Gostout, MD

Investigator Role:

Study Director

Investigator Affiliation:

Mayo Clinic, Rochester, MN

Authority:

United States: Food and Drug Administration

Study ID:

5-06

NCT ID:

NCT00587236

Start Date:

March 2006

Completion Date:

August 2010

Related Keywords:

  • Colitis, Ulcerative
  • Cholangitis, Sclerosing
  • Autofluorescence
  • Narrow Band
  • High definition white light
  • Cholangitis
  • Cholangitis, Sclerosing
  • Colitis
  • Colitis, Ulcerative
  • Ulcer

Name

Location

Mayo ClinicRochester, Minnesota  55905