A Trial of Percutaneous vs. Endoscopic Drainage of Suspected Klatskin Tumors (NCT03172832) | Clinical Trial Compass
TerminatedNot Applicable
A Trial of Percutaneous vs. Endoscopic Drainage of Suspected Klatskin Tumors
Stopped: Slow accrual; recommended by DSMB.
United States13 participantsStarted 2017-08-20
Plain-language summary
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.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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