Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction

Launched by ERASMUS MEDICAL CENTER · Nov 1, 2024

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Eligibility criteria

• Inclusion Criteria:
• • Written informed consent must be given according to ICH/GCP and national/local regulations.
• • MHBO on imaging with histopathological confirmation or high clinical suspicion.
• • Ineligible for surgical resection.
• • Hyperbilirubinemia (a combination of a total bilirubin level \>50 mmol/l.
• Exclusion Criteria:
• • Fluctuation or spontaneous decrease of a total bilirubin level before start of any treatment suggesting a potential non-malignant diagnosis.
• • Patients who underwent previous biliary drainage procedures endoscopically or percutaneously. Patients who underwent an attempted but failed ERCP are eligible only when no papillotomy or cannulation was performed.
• • Clinical signs of cholangitis. Cholangitis is defined as the presence of both fever (i.e. body temperature \>38.5°C) and leucocytosis (i.e. ≥10 \*109/L) without clinical or radiological evidence of acute cholecystitis (22).
• • Uncorrectable coagulation disorder.
• • Uncorrectable contrast allergy.