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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:
ClinicalTrials.gov Identifier:
NCT00951327
First Posted: August 4, 2009
Last Update Posted: August 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
  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:


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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951327


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Todd H. Baron MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00951327     History of Changes
Other Study ID Numbers: 08-006221
First Submitted: July 31, 2009
First Posted: August 4, 2009
Last Update Posted: August 4, 2010
Last Verified: August 2010

Keywords provided by Mayo Clinic:
Primary sclerosing cholangitis

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