Status:
COMPLETED
Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy
Lead Sponsor:
University Hospital, Geneva
Conditions:
Cholelithiasis
Cholecystitis
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate if cholecystectomy first (studied group) versus sequential common bile duct imaging/cholecystectomy (control group) result in a decrease of hospital stay, morb...
Detailed Description
Emergency cholecystectomy is nowadays an accepted surgical procedure routinely performed worldwide. The main indications include acute cholecystitis, cholangitis and gallstone migration. Abnormal live...
Eligibility Criteria
Inclusion
- Patients must have a clinical diagnosis of gallstone migration, defined as right upper quadrant or epigastric abdominal pain and abnormal liver function tests (increase of at least two common hepatic parameters \[AST, ALT, alkaline phosphatase, gGT and/or bilirubin\], with one of them being either AST or ALT with a value at least two times higher than the norm) with a reasonable exclusion of other common differential diagnoses
- Patients will be included regardless the presence of an associated cholecystitis, defined as right upper quadrant abdominal pain, radiological signs of cholecystitis (including radiological Murphy sign and/or thickened gallbladder wall and/or free abdominal fluid around the gallbladder) and signs of infection (including fever, increased CRP or white blood cell count)
- Age ≥ 16 years
Exclusion
- Presence of CBD stone on CT or US performed on admission (which will require ERCP exploration prior to surgery)
- Associated radiologically proven gallstone pancreatitis
- Associated cholangitis
- Medical conditions preventing surgery such as acute stroke, acute coronary syndrome, severe cardiac failure (NYHA class IV and/or respiratory failure with SpO2 \< 85% with room air and/or LVEF \< 35%), severe COPD with VEMS \< 30 % of predicted value
- Medical conditions preventing informed consent
- Patients with contraindications to MRI (MRI-incompatible electronic devices \[e.g. pacemakers\], implants or prostheses, vascular clips less than 2 weeks, severe claustrophobia) and to EUS/ERCP (surgery with gastric diversion, severe cardiac dysfunction)
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01492790
Start Date
June 1 2011
End Date
August 1 2013
Last Update
August 13 2013
Active Locations (1)
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1
Geneva University Hospitals
Geneva, Switzerland, 1211