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Table 1 Definitions of severe drainage-related complications

From: Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trial

Complication

Criteria

Cholangitis

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

Acute cholecystitis

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

Persistent jaundice

Persistent elevated bilirubin levels after primary technically and clinically successful drainage had initially been obtained, without signs of cholangitis or cholecystitis, requiring a reintervention.

Acute pancreatitis

Two or more of the following criteria be met for the diagnosis of acute pancreatitis: abdominal pain suggestive of pancreatitis, serum amylase or lipase level greater than three times the upper normal value, or characteristic imaging findings.

Biliary leak

Symptomatic intra-abdominal bile leakage due to bile duct perforation or leakage from the puncture tract documented by any radiographic technique requiring intervention.

Haemorrhage

Clinical evidence of bleeding requiring blood transfusion or reintervention.