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

Djamila Boerma,Kirsten Kortram,Marc G H Besselink,Grard A P Nieuwenhuijzen,Philip M Kruyt,Thomas L Bollen,Ellen Tromp,Tom Karsten,Dirk J Gouma,Bert van Ramshorst,Johannes C Kelder

doi:10.1186/1745-6215-13-7

Abstract

BackgroundLaparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice.Methods/DesignThe 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.DiscussionThe 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.Trial RegistrationNetherlands Trial Register (NTR): NTR2666

Highlights

Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality
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
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 laparoscopic cholecystectomy (LC) in these patients can result in serious morbidity and mortality

Summary

Introduction

Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. Acute calculous cholecystitis (ACC) is a frequently encountered disease in the general surgical practice. There is a remaining subgroup of patients who can be defined as “high risk patients” based on their comorbidity. 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.

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