Clinical Trial: Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis: A Randomized Prospective Study
Brief Summary: 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 Summary:
Acute pancreatitis is a prevalent disease, responsible for 220.000 hospital admissions per year in the USA. 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.
Sponsor: Hospital del Salvador
Current Primary Outcome: hospital stay [ Time Frame: Through study completion (approximately two years) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: perioperative complications [ Time Frame: within 30 days ]
Original Secondary Outcome: Same as current
Information By: Hospital del Salvador
Dates:
Date Received: October 27, 2015
Date Started: December 2015
Date Completion: November 2017
Last Updated: December 30, 2015
Last Verified: December 2015
