Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy (CCK first)
|ClinicalTrials.gov Identifier: NCT01492790|
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : August 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cholelithiasis Cholecystitis||Procedure: Emergency cholecystectomy first Procedure: Sequential common bile duct imaging/cholecystectomy||Not Applicable|
Emergency cholecystectomy is nowadays an accepted surgical procedure routinely performed worldwide. The main indications include acute cholecystitis, cholangitis and gallstone migration. Abnormal liver function tests upon admission and suspicion for accompanying common bile duct (CBD) stone can delay the surgical management due to the need for further investigations and/or therapeutic maneuvers. These procedures include magnetic resonance cholangio-pancreatography (MRCP), endoscopic ultrasound (EUS) and endoscopic retrograde cholangio-pancreatography (ERCP).
While useful to detect or exclude potential CBD stones, these procedures include inherent risks, delay the surgical treatment, extend hospital stay and as a result, increase the overall medical costs. They can also potentially increase the morbidity and/or mortality by delaying emergency cholecystectomy (due to the presence of more local inflammation and adherence). Finally, more and more centers perform systematic intra-operative cholangiogram during cholecystectomies (laparoscopic or open), which allow an accurate assessment of the CBD and potentially lead to its subsequent exploration (endoscopic or surgical).
In this study, the investigators will assess the following hypotheses:
- Patients with a SUSPICION of gallstone migration (with or without associated cholecystitis) should undergo emergency cholecystectomy with intra-operative cholangiogram (IOC) first
- "Cholecystectomy first" strategy will decrease both the length of hospital stay and the morbidity/mortality by decreasing the number of unnecessary EUS, MRCP and ERCP and therefore decreasing the overall number of their complications, as well as decreasing the complications related to delayed cholecystectomy (increased adherences due to inflammation, especially in case of associated cholecystitis, which increase the risk of bleeding, CBD lesion, duodenal lesion, gastric lesion, colon lesion, gallbladder perforation and intra-abdominal gallstones spillage with potential
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Randomized Study Comparing Emergency Cholecystectomy First Versus Sequential Common Bile Duct Imaging/Cholecystectomy for the Management of Gallstone Migration|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||August 2013|
Experimental: Cholecystectomy first
Patients enrolled in this arm will undergo emergency cholecystectomy first without any common bile duct imaging
Procedure: Emergency cholecystectomy first
The intervention is an emergency cholecystectomy without prior common bile duct imaging
Active Comparator: Sequential common bile duct imaging/cholecystectomy
Patients enrolled in this arm will undergo common bile duct imaging and, if needed, ERCP first followed by emergency cholecystectomy
Procedure: Sequential common bile duct imaging/cholecystectomy
This intervention is a common bile duct imaging modality and, if needed, ERCP first followed in the same hospital stay by a cholecystectomy
- Hospital stay [days] [ Time Frame: 0 - 30 days ]We will evaluate if our "new treatment" arm will have a decreased hospital stay. We do not expect patients to stay more than 30 days.
- Morbidity [ Time Frame: 6 months ]We will follow-up patients until 6 months after their operation (cholecystectomy) and compare if there is any statistically significant difference between the two arms of the study in terms of morbidity.
- Mortality [ Time Frame: 6 months ]We will follow-up patients until 6 months after their operation (cholecystectomy) and compare if there is any statistically significant difference between the two arms of the study in terms of mortality.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492790
|Geneva University Hospitals|
|Geneva, Switzerland, 1211|
|Principal Investigator:||Pouya Iranmanesh, MD||University Hospital, Geneva|