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

The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs.The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients.Netherlands Trial Register (NTR): NTR2666Acute calculous cholecystitis (ACC) is a frequently encountered disease in the general surgical practice. In young, otherwise healthy patients laparoscopic cholecystectomy (LC) is the treatment of choice [1]. In elderly patients with major comorbidity and seriously ill patients, especially those already admitted to an intensive care unit, percutaneous cholecystostomy (PC) seems preferable since acute LC in these patients can result in serious morbidity (up to 41%[2-7]) and mortality (up to 4.5%[2-6,8]). But there is a remaining subgroup of patients who can be defined as "high risk patients" based on their comorbidity or disease severity but do not fit in either of the two afore-mentioned categories.Both LC and PC are often used in this subgroup of patients but clear selection criteria for either treatment are lacking and a number of questions regarding the safety and efficacy of PC remain.In the Dutch guidelines for the treatment of gallstone disease [9] PC is indicated as a useful treatment option in patients deemed unfit for surgery but it is left open to discussion whether routine use