The CHOCOLATE randomized controlled trial (RCT) compared morbidity and mortality with laparoscopic cholecystectomy (n=66; mean age, 71.4 years) versus percutaneous catheter drainage (n=68; mean age, 74.9 years) performed within 24 hours of presentation in high-risk patients with acute calculous cholecystitis (ACC) at 11 teaching hospitals in the Netherlands. Mortality at one year did not significantly differ between the cholecystectomy and drainage groups, but the rates of major complications (65% vs. 12%), need for reintervention at one year (66% vs. 12%), and recurrent biliary disease at one year (53% vs. 4.5%) were all higher in the drainage group. In addition, median length of stay was longer in the drainage group than in the cholecystectomy group (9 vs. 5 d; P<0.001).
Congratulations to Loozen and colleagues for addressing the vexing clinical problem of which patients with ACC are surgical candidates and which would be better served by a temporizing measure, such as percutaneous drainage. Despite an increase in admissions for ACC in the Western hemisphere over the past decade, no prior RCTs have addressed the question asked by Loozen and colleagues. The well-designed, multicenter CHOCOLATE study showed that older patients with non–life-threatening comorbidities benefit from early surgical intervention.
The results of the trial would have been more generalizable if it had included patients with a broader age range, given that ACC affects adults of all ages. Additionally, the results of the trial for length of stay and hospital costs are not directly applicable to patients in the USA due to differences in hospital processes and financing between the USA and The Netherlands. Finally, the use of the APACHE scoring system to address physiologic compromise may be limited, given that it is designed to address survival. A system, such as the Tokyo criteria, would have been a better measure of physiologic derangement.
Despite its limitations, the CHOCOLATE trial may change treatment by surgeons and internists who care for such patients and is an important step in solving a unique clinical dilemma.