Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis

Study Overview
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Brief Summary
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Randomized controlled trial to demonstrate the safety of early cholecystectomy (<72h) in patients with mild gallstone pancreatitis. The purpose of this study is to demonstrate that there is a shorter hospital stay and no higher complication rates.

Detailed Description
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Acute pancreatitis is a prevalent disease, responsible for 220.000 hospital admissions per year in the United States of America. In Chile, during year 2012 there were 76.463 hospital admissions for this diagnosis, with a mean hospital stay of 11,8 days and 25 deaths per year associated with this disease (250 deaths from 2002 to 2012). The most frequent etiology of pancreatitis in Chile is gallstones, which can be present in 80% of the patients admitted for acute pancreatitis. This can be explained by the high prevalence of gallstones among these patients. Since Acosta and Ledesma demonstrated the association between gallstones and acute pancreatitis in 1974, cholecystectomy has been the most efficient treatment option to prevent recurrence that can reach even 30-40% in the first two weeks after the first episode. There is consensus in delaying the time of the cholecystectomy in patients with acute gallstone pancreatitis where mortality can be as high as 80% in patients presenting with severe cases. However, the vast majority of the patients will present with a mild pancreatitis requiring no more than basic medical support. In these patients, the role of surgery during the same hospital admission has been clearly demonstrated. There is no current consensus with respect to the safety of performing cholecystectomy in patients with mild pancreatitis within 48 to 72 hours after the hospital admission. There are few well-designed observational studies and only one randomized clinical trial, which has demonstrated a significant decrease in hospital stay (7 to 4 days), without increasing the rate of complications or mortality. According to some models of analysis and decision, this strategy could reduce costs associated with prolonged hospital stays and improve the quality of life of these patients without jeopardizing patient safety.

Official Title
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Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis: A Randomized Prospective Study

Conditions
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Gallstone Pancreatitis

Intervention / Treatment
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* Procedure: Early cholecystectomy
* Procedure: Control (Delayed cholecystectomy)


Participation Criteria
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Eligibility Criteria
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Patients aged 18-70 years admitted with first gallstone acute pancreatitis (GAP) is evaluated for eligibility. Diagnosis and severity of GAP is based upon Atlanta Consensus modified at 2012. Acute pancreatitis is diagnosed when at least two out of three criteria are met; acute upper abdominal pain, elevated serum amylase/lipase level (more than thrice upper limit of normal range) and evidence of pancreatitis at any imaging modality (abdominal ultrasonography, computed tomography or magnetic resonance image). Biliary etiology is verified by abdominal ultrasonography showing stones or sludge at gallbladder. All other etiologies should be excluded. Exclusions criteria: (1) acute cholecystitis at abdominal ultrasonography, (2) suspected or confirmed acute cholangitis according to 2013 Tokyo Guidelines (fever or laboratory data with inflammatory response, cholestasis and imaging study with biliary dilatation/evident etiology), (3) history of Roux en Y gastric by pass or open supraumbilical surgery, (4) acute alcohol consumption, (5) chronic hepatic/pancreatic disease, (6) comorbidities contraindicating emergency surgery, (7) mental condition that preclude informed consent, (8) pregnancy, (9) patient refusal, (10) no endoscopist availability. There is no exclusions based on choledocolithiasis risk. All patients must complete clinical, anthropometric, and general laboratory/liver function tests at admission and daily until third day of stay or surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Early cholecystectomy<br>Cholecystectomy within the first 72 hours of admission. | Procedure: Early cholecystectomy<br>* Cholecystectomy + intraoperative cholangiography within the first 72 hours of admission.<br>|
| Other: Control (Delayed cholecystectomy)<br>Standard care arm. Cholecystectomy is delayed until normalization of laboratory values, abdominal pain resolves and oral intake is restored. | Procedure: Control (Delayed cholecystectomy)<br>* Standard care arm. Cholecystectomy + intraoperative cholangiography is delayed once complete resolution of abdominal tenderness, oral feeding and trending down in pancreatic laboratory is achieved<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay (LOS) | days | 90 dias | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic retrograde cholangio-pancreatography (ERCP) | yes/no | 90 days | 
| Conversion | yes/no | surgery | 
| Wound infection | yes/no | 30 days | 
| Re-admission | yes/no | 90 days | 
| Biliary complications | biloma, bile leak, residual choledocholithiasis | 90 days | 
| Operative time | operative time in minutes | surgery | 
| medical complications | any medical complication using Clavien-dindo classification | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gallstone pancreatitis, mild acute pancreatitis, adult