Laparoscopic cholecystectomy versus percutaneous catheter drainage for acute cholecystitis in high risk patients (CHOCOLATE): multicentre randomised clinical trial

Abstract

ObjectiveTo assess whether laparoscopic cholecystectomy is superior to percutaneous catheter drainage in high risk patients with acute calculous cholecystitis.DesignMulticentre, randomised controlled, superiority trial.Setting11 hospitals in the Netherlands, February 2011 to January 2016.Participants142 high risk patients with acute calculous cholecystitis were randomly allocated to laparoscopic cholecystectomy (n=66) or to percutaneous catheter drainage (n=68). High risk was defined as an acute physiological assessment and chronic health evaluation II (APACHE II) score of 7 or more.Main outcome measuresThe primary endpoints were death within one year and the occurrence of major complications, defined as infectious and cardiopulmonary complications within one month, need for reintervention (surgical, radiological, or endoscopic that had to be related to acute cholecystitis) within one year, or recurrent biliary disease within one year.ResultsThe trial was concluded early after a planned interim analysis. The rate of death did not differ between the laparoscopic cholecystectomy and percutaneous catheter drainage group (3% v 9%, P=0.27), but major complications occurred in eight of 66 patients (12%) assigned to cholecystectomy and in 44 of 68 patients (65%) assigned to percutaneous drainage (risk ratio 0.19, 95% confidence interval 0.10 to 0.37; P<0.001). In the drainage group 45 patients (66%) required a reintervention compared with eight patients (12%) in the cholecystectomy group (P<0.001). Recurrent biliary disease occurred more often in the percutaneous drainage group (53% v 5%, P<0.001), and the median length of hospital stay was longer (9 days v 5 days, P<0.001).ConclusionLaparoscopic cholecystectomy compared with percutaneous catheter drainage reduced the rate of major complications in high risk patients with acute cholecystitis.Trial registrationDutch Trial Register NTR2666.

Percutaneous Cholecystostomy for Acute Calculous Cholecystitis in Elderly Patients

“…ATK'nın tedavisinde cerrahi ve özellikle LK günümüzde kabul edilen en uygun tedavidir (8). ATK olgularının büyük çoğunluğu yaşlı hastalarda olmaktadır ve bu olgular gençlere göre daha şiddetli seyretmektedir.…”

“…PK işlemi ile ilgili en temel sorun, özellikle ATK hastalarında altta yatan patoloji düzeltilemediğinden, taşa bağlı biliyer semptomların tekrarlayabilmesi ve PK'nin sadece geçici bir çözüm sağlamasıdır (8). Winbladh ve ark.…”

“…Yaşlı hastaların rezervlerinin düşük, komorbiditelerinin fazla olması sebebiyle, yapılacak bir cerrahinin perioperatif morbidite ve mortalite oranlarının da fazla olabileceği düşünülmektedir. Ancak bununla ilgili birbirinden farklı sonuçlar veren yayınlar mevcuttur (7,8). Bizim bu çalışmadaki amacımız, yaşlı hastalarda (≥65) PK'nin etkinliğini, güvenilirliğini ve ATK rekürrens oranları ile tekrar işlem gerekliliğini araştırmaktır.…”

Advances in the management of acute cholecystitis

“…They were also less likely to undergo cholecystectomy in the following 2 years after hospitalization, had longer hospital stays and more complications . One recent randomized trial from the Netherlands in patients with an APACHE II score of >7 was abandoned after they found significantly higher reintervention and morbidity in the PC group . These conflicting results imply that more specific studies need to be conducted on the precise indications for PC.…”

Looking for the best practice for acute cholecystitis

“…Furthermore, the authors sounded the alarm regarding the high incidence of biliary injury in subsequent cholecystectomy after PC (1.6%). Very recently, a multicenter randomized clinical trial (the CHOCOLATE trial) comparing PC with LC in high‐risk patients was published . In total, 142 patients with acute calculous cholecystitis were randomly allocated to two treatment protocols.…”