Table 2 Definitions of severe complications in the primary outcome measure

Cholangitis

Elevation in temperature more than 38,5°C and Leukocytes ≥10 *10⁹/L, thought to have a biliary cause, without concomitant evidence of acute cholecystitis, requiring invasive intervention.

Acute cholecystitis

Radiologic evidence of cholecystitis, elevation in temperature more than 38.5°C and Leukocytes ≥10*10⁹/L, and requirement of percutaneous drainage or emergency cholecystectomy.

Stent/ catheter dysfunction

Rising bilirubin level after therapeutic success had initially been obtained, without signs of cholangitis or cholecystitis, requiring new cannulation of the tumor.

Acute pancreatitis

Abdominal pain and a serum concentration of pancreatic enzymes (amylase or lipase) ≥3 times the upper limit of normal, that requires ≥1 one night of hospitalization.

Hemorrhage

Clinical evidence of bleeding with the need of a blood transfusion.

Perforation

Retroperitoneal or bowel-wall perforation documented by any radiographic technique requiring intervention.

Portal vein thrombosis

Clinical evidence of thrombosis confirmed on colour Doppler US as absence of flow compatible with occlusion, precluding liver surgery.

Dehydration

Severe dehydration with electrolyte disturbances resulting from excessive fluid loss through externally draining catheters, requiring rehydration in the clinical setting.