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Table 2 In- and exclusion criteria for eligibility for participation in the CHOCOLATE trial.

From: Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial

Inclusion Criteria Exclusion Criteria
- Age ≥ 18
- The diagnoses acute calculous cholecystitis defined according to the Tokyo Guidelines:
A. Local signs of inflammation: (1) Murphy's sign, (2) Right upper quadrant mass/pain/tenderness
B. Systemic signs of inflammation: (1) Fever, (2) elevated CRP, (3) elevated WBC count
C. Imaging findings: imaging findings characteristic of acute cholecystitis
Definite diagnosis:
(1) One item in A and one item in B are positive
(2) C confirms the diagnosis when acute cholecystitis is suspected clinically
- APACHE-II score ≥ 7 AND ≤ 14
- Written informed consent
- Onset of symptoms > 7 days before first presentation
- Already admitted to ICU on presentation
- Pregnancy
- APACHE-II score ≤ 6 OR ≥ 15
- Acalculous cholecystitis
- Decompensated liver cirrhosis
- Mental illness prohibiting informed consent