A Trial of Percutaneous vs. Endoscopic Drainage of Suspected Klatskin Tumors

Stopped early · Not applicable

Conditions studied: Cholangiocarcinoma, Hilar Lymphadenopathy, Biliary Stricture

In brief

The optimal approach to the drainage of malignant obstruction at the biliary hilum remains uncertain. This is a randomized comparative effectiveness study of percutaneous transhepatic biliary drainage (PTBD) vs. endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction.

Key facts

Study ID

NCT03172832

Run by

Medical University of South Carolina

People needed

13

Starts

2017-08-20

Expected to finish

2019-04-12

Last updated by the study team

2020-03-25

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥40 (to reduce the likelihood of enrolling patients with obstruction due to primary sclerosing cholangitis)
• Cholestatic liver function tests, including serum alkaline phosphatase level ≥ 300 IU/L and bilirubin level ≥ 3.7 mg/dL
• Radiographic evidence of a biliary hilar stricture OR intrahepatic but no extrahepatic biliary ductal dilation

You may not qualify if…

• Known radiographic evidence of a Bismuth-Corlette type 1 biliary stricture
• Known diagnosis of primary sclerosing cholangitis without suspicion of dominant hilar stricture
• Recent gallbladder/biliary surgery within 12 months
• Known Mirizzi syndrome
• Known IgG4-mediated cholangiopathy
• Significant liver metastatic disease interfering with safe/effective PTBD
• Significant ascites interfering with safe/effective PTBD
• Known regional malignant-appearing adenopathy or extra-biliary mass, indicating the need for concurrent EUS-FNA
• Prior ERCP or PTBD for hilar obstruction
• Surgically altered luminal anatomy other than prior Billroth reconstruction or Whipple resection
• Standard general contraindications to ERCP or PTBD (e.g. hemodynamic instability, uncorrected coagulopathy, etc.)
• Inability or unwillingness to follow study protocol

Where it is running

• University of Southern California — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Yale University — New Haven, Connecticut, United States
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• University of Florida - Jacksonville — Jacksonville, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston University — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Dartmouth University — Lebanon, New Hampshire, United States
• Stony Brook University — Stony Brook, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Methodist Hospital Dallas — Dallas, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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