Table 2 Secondary endpoint: definitions

Cholangitis

All of the following features (as previously defined) [20]:

1) Serum total bilirubin level >40 μmol/l (>2.3 mg/dl) and/or dilated common bile duct (>6 mm) on transabdominal or endoscopic ultrasound or computed tomography;

2) Temperature >38.5°C.

Organ failure

Failure of one or more of the following organ systems [19]:

1) Respiratory: PaO₂ ≤60 mmHg or need for mechanical ventilation;

2) Cardiovascular: systolic blood pressure <90 mmHg or need for catecholamine support;

3) Renal: creatinine level >177 μmol/l after rehydration or need for hemofiltration or hemodialysis (not including pre-existent renal failure).

Biliary leakage

Defined according to the Amsterdam criteria [23]:

Type A: cystic duct leaks or leakage from aberrant or peripheral hepatic radicals;

Type B: major bile duct leaks with or without concomitant biliary strictures;

Type C: bile duct strictures without bile leakage;

Type D: complete transection of the duct with or without excision of some portion of the bile duct.