Clinical Trial: Early Versus Delayed Surgery for Gallstone Pancreatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Early Versus Delayed Surgery for Gallstone Pancreatitis: A Prospective Randomized

Brief Summary: While there exists consensus among surgeons that patients with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, the precise timing of laparoscopic cholecystectomy for mild to moderate disease remains controversial. We hypothesize that laparoscopic cholecystectomy performed within 48 hours of admission, regardless of resolution of abdominal pain or abnormal laboratory values, will result in a shorter hospital stay.

Detailed Summary:

Acute pancreatitis is a common diagnosis worldwide, with more than 220,000 cases reported annually in the United States alone. The leading etiology is gallstones.1 Gallstone pancreatitis is thought to occur due to transient obstruction of the common channel that drains both the biliary and pancreatic ducts, resulting in inflammation of the pancreas. The pancreatitis that ensues is usually mild and self-limited and the treatment is initially supportive with subsequent laparoscopic cholecystectomy (LC). However, a small subgroup of patients develop severe pancreatitis and/or concomitant cholangitis. When the latter is present, ERC and sphincterotomy with stone extraction as indicated are typically performed.

While there is a clear consensus that patients who present with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, precise timing of surgery remains controversial. In patients with severe pancreatitis (Ranson's > 3), there is consensus that surgery is delayed until the pancreatitis has resolved because early operation is associated with a higher complication rate. 2 However, despite more than 30 years of debate in the surgical literature, the optimal timing of surgery in mild to moderate pancreatitis (Ranson's ≤ 3) remains unclear. With recurrence rates for gallstone pancreatitis reported as high as 63%3 and with some of the repeat attacks occurring within two weeks of initial index presentation1, most investigators have recommended cholecystectomy during the initial hospitalization.4,5 Still, the actual timing of surgery during the initial index hospitalization is unsettled. In practice, surgeons often delay surgery until there is evidence of complete resolution of the inflammatory process, as evidenced by absence of abdominal pain and normalization of liver functional tests and pancreatic enzymes.6 Unfortunately, this strategy may re
Sponsor: Los Angeles Biomedical Research Institute

Current Primary Outcome: Length of hospital stay [ Time Frame: Days in the hospital ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Rates of conversion to open surgery, complication rates and rates of need for endoscopic retrograde cholangiogram [ Time Frame: Within 30 days ]

Original Secondary Outcome: Same as current

Information By: Los Angeles Biomedical Research Institute

Dates:
Date Received: March 16, 2009
Date Started: November 2007
Date Completion:
Last Updated: September 25, 2011
Last Verified: September 2011