Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy (CCK first)
| Tracking Information | |||||
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| First Received Date ICMJE | December 13, 2011 | ||||
| Last Updated Date | February 28, 2013 | ||||
| Start Date ICMJE | June 2011 | ||||
| Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Hospital stay [days] [ Time Frame: 0 - 30 days ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01492790 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy | ||||
| Official Title ICMJE | An Open Randomized Study Comparing Emergency Cholecystectomy First Versus Sequential Common Bile Duct Imaging/Cholecystectomy for the Management of Gallstone Migration | ||||
| 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, morbidity/mortality and costs in the management of patients with a suspicion of gallstone migration. |
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| Detailed Description | 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:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | August 2013 | ||||
| Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01492790 | ||||
| Other Study ID Numbers ICMJE | CER 11-045 (NAC 11-012) | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pouya Iranmanesh, University Hospital, Geneva | ||||
| Study Sponsor ICMJE | University Hospital, Geneva | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Geneva | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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