Laparoscopic cholecystectomy versus radiological drainage of the gallbladder in acute cholecystitis.

Acute calculous cholecystitis is a frequently encountered problem in the surgical practice and laparoscopic cholecystectomy (LC) is still the standard treatment for patients without significant comorbidity and therefore low-moderate risks on intervention. In elderly patients or patients with significant comorbidity, surgery in general is associated with higher complication rates and even mortality. Percutaneous cholecystostomy (PC) may be an alternative, and in the current surgical practice many surgeons prefer this method over LC in acute calculous cholecystitis in patients with increased risks. Because the gallbladder remains in situ, the infection can worsen mandating an emergency LC which can be even more difficult, and there is always the risk of recurrence.

The CHOCOLATE Trial is initiated to determine superiority of the laparoscopic cholecystectomy over percutaneous drainage in the treatment of acute cholecystitis in patients with increased risk. It is designed as a multi centre randomized controlled trial, including patients with acute calculous cholecystitis with increased risk (defined as APACHE score ≥6 AND ≤14). Patients will be randomized to either laparoscopic cholecystectomy or percutaneous drainage of the gallbladder. The endpoint is a combined endpoint of all procedure related morbidity and mortality with a total duration of follow up of one year.

Laparoscopic cholecystectomy is the preferred therapy for all patients eligible for surgery with acute calculous cholecystitis.

Iclusion will approximately take two years, follow up will be one year.

An interim analysis will be performed every three months.

1. Laparoscopic Cholecystectomy;

2. Percutaneous Cholecystostomy.