|- candidate number||8832|
|- NTR Number||NTR2666|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-dec-2010|
|- Secondary IDs||R-10.30A VCMO Antonius Hospital Nieuwegein|
|- Public Title||Laparoscopic cholecystectomy versus radiological drainage of the gallbladder in acute cholecystitis.|
|- Scientific Title||Laparoscopic cholecystectomy versus percutaneous cholecystostomy in acute calculous cholecystitis in high risk patients.|
|- hypothesis||Laparoscopic cholecystectomy is the preferred therapy for all patients eligible for surgery with acute calculous cholecystitis.|
|- Healt Condition(s) or Problem(s) studied||Acute calculous cholecystitis|
|- Inclusion criteria||1. APACHE-II score greater than or equal to 7 AND smaller than or equall to 14;|
2. Acute calculous cholecystitis, defined according to Tokyo Guidelines;
3. Written informed consent.
|- Exclusion criteria||1. < 18 years of age;|
2. Onset of symptoms lesser than or equal to 7 days before first presentation;
3. Already admitted to ICU;
5. APACHE-II score smaller than or equal to 6 OR greater than or equal to 15;
6. Acalculous cholecystitis;
7. Decompensated liver cirrhosis;
8. Mental illness prohibiting informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||1-feb-2014|
|- Target number of participants||302|
|- Interventions||1. Laparoscopic Cholecystectomy;|
2. Percutaneous Cholecystostomy.
|- Primary outcome||1. Mortality;|
2. All procedure related major morbidity (Infectious complications, cardio-pulmonary complications, need for re-intervention, recurrent biliary disease).
|- Secondary outcome||1. All individual components of primary endpoint;|
2. Length of hospital admission;
3. Time to full recovery;
4. Cost-effectiveness analysis.
|- Timepoints||Iclusion will approximately take two years, follow up will be one year.|
An interim analysis will be performed every three months.
|- Trial web site||www.cholecystitis.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. D. Boerma|
|- CONTACT for SCIENTIFIC QUERIES||MD. D. Boerma|
|- Sponsor/Initiator ||Sint Antonius Ziekenhuis|
(Source(s) of Monetary or Material Support)
|St Antonius Hospital, Nieuwegein|
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||27-dec-2010 - 4-okt-2011|