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Table 2 Secondary endpoint: definitions

From: Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial

Biliary event Definition
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.