Background
Methods
Design
Patients
Inclusion criteria |
1. Age ≥ 40 years (to reduce the likelihood of enrolling patients with obstruction due to primary sclerosing cholangitis) |
2. Cholestatic liver function tests, including serum alkaline phosphatase level ≥ 300 IU/L and bilirubin level ≥ 3.7 mg/dL |
3. Radiographic evidence of a biliary hilar stricture or intrahepatic but no extrahepatic biliary ductal dilation |
Exclusion criteria |
1. Known radiographic evidence of a Bismuth-Corlette type 1 biliary stricture |
2. Known diagnosis of primary sclerosing cholangitis without suspicion of dominant hilar stricture |
3. Recent cholecystectomy, liver resection, or biliary surgery within 12 months |
4. Known Mirizzi syndrome |
5. Known IgG4-mediated cholangiopathy |
6. Significant liver metastatic disease interfering with safe/effective PTBD |
7. Significant ascites interfering with safe/effective PTBD |
8. Known regional malignant-appearing adenopathy or extrabiliary mass, indicating the need for concurrent EUS-FNA |
9. Prior ERC or PTBD for hilar obstruction |
10. Surgically altered luminal anatomy other than prior Billroth reconstruction |
11. Standard general contraindications to ERC or PTBD (e.g., hemodynamic instability, uncorrected coagulopathy, etc.) |
12. Pregnancy |
13. Inability or unwillingness to follow study protocol |