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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00951327
Other study ID # 08-006221
Secondary ID
Status Completed
Phase N/A
First received July 31, 2009
Last updated August 3, 2010
Start date November 2008
Est. completion date August 2010

Study information

Verified date August 2010
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. One year No
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