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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing ERCP.

Brief Summary:

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.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: July 31, 2009
Date Started: November 2008
Date Completion:
Last Updated: August 3, 2010
Last Verified: August 2010