Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis
Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis
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.
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.
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.