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Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing Endoscopic Retrograde Cholangiopancreatogram (ERCP)

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00951327
First received: July 31, 2009
Last updated: August 3, 2010
Last verified: August 2010
History of Changes
  Purpose

Patients with primary sclerosing cholangitis (PSC) are affected by an inflammatory condition of the bile ducts. Unfortunately, patients with PSC have a 10 to 15 percent lifetime risk of developing gallbladder and bile duct cancers. Gallbladder and bile duct cancers have a five-year survival of only 5 to 10 percent. Surgery to provide a cure must remove all cancer confined to one area.

In order to increase survival rates there is a need to identify cancer and pre-cancer early. This has been difficult to do.

Patients who have lab tests, positive imaging tests or obstructions will usually have a test called ERCP (Endoscopic Retrograde Cholangiopancreatogram) to take biopsies and enlarge bile ducts or opening bile ducts with stents. Patients usually have cells in the bile ducts removed and analyzed, but there are not studies to show how sensitive this may be to determine if the cells are cancer or pre-cancerous. A new scope with a system using light filters called Narrow Band Imaging (NBI) may help detect cancer and pre-cancer more often and at an earlier stage.


Condition
Primary Sclerosing Cholangitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing ERCP.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Endoscopy
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Cholangioscopy with NBI will enhance the ability to identify sites of potential dysplasia or malignancy in patients with PSC and will be more sensitive in identifying dysplasia than ERCP with biliary brushing and fluoroscopy-guided forceps biopsy. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
  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 for ERCP with history of Primary Sclerosing Cholangitis

Criteria

Inclusion Criteria:

  • Patients with PSC presenting for ERCP where tissue sampling is indicated
  • Adults age 18 to 75 years old
  • Able to give informed written consent
  • Either male or female

Exclusion Criteria:

  • PSC with acute cholangitis
  • Patients with acute or chronic, debilitating cardiopulmonary disease who are unable to safely undergo prolonged conscious sedation
  • Patients with a prior history of liver transplant
  • Prisoners
  • Unable or unwilling to give informed consents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951327

Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Todd H. Baron MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00951327     History of Changes
Other Study ID Numbers: 08-006221
Study First Received: July 31, 2009
Last Updated: August 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Primary sclerosing cholangitis

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013