Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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An Open Randomized Study Comparing Emergency Cholecystectomy First Versus Sequential Common Bile Duct Imaging/Cholecystectomy for the Management of Gallstone Migration

Conditions
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Cholelithiasis, Cholecystitis

Intervention / Treatment
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* Procedure: Emergency cholecystectomy first
* Procedure: Sequential common bile duct imaging/cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholecystectomy first<br>Patients enrolled in this arm will undergo emergency cholecystectomy first without any common bile duct imaging | Procedure: Emergency cholecystectomy first<br>* The intervention is an emergency cholecystectomy without prior common bile duct imaging<br>|
| Active Comparator: Sequential common bile duct imaging/cholecystectomy<br>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<br>* This intervention is a common bile duct imaging modality and, if needed, ERCP first followed in the same hospital stay by a cholecystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay [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. | 0 - 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | 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. | 6 months | 
| Mortality | 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. | 6 months |