Early Versus Delayed Surgery for Gallstone Pancreatitis
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.
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 result in prolongation of hospitalization without any proven benefit.
A previous prospective, non-randomized study from our institution suggested that early cholecystectomy could safely be performed within 48 hours of admission in patients with mild to moderate pancreatitis, regardless of resolution of abdominal pain and abnormal laboratory values. In this study, when compared to a retrospective control group in which surgery was delayed until there was resolution of clinical and laboratory parameters, hospital stay was significantly reduced from a median of 7 days to 4 days, without additional complications.7 In order to address the optimal timing of surgery in a more definite fashion, a prospective randomized study was performed in which patients with mild to moderate gallstone pancreatitis were allocated to either an early group (surgery within 48 hours of presentation) or a control group (surgery after resolution of abdominal pain and normalization of laboratory values) and assessed overall outcomes.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Laparoscopic cholecystectomy within 48 hours of admission, Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values
Harbor-UCLA Medical Center
Active, not recruiting
Los Angeles Biomedical Research Institute
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00863642
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Excision of the gallbladder through an abdominal incision using a laparoscope.
Surgical removal of the GALLBLADDER.
Placement of one of the surgeon's gloved hands into the ABDOMINAL CAVITY to perform manual manipulations that facilitate the laparoscopic procedures.
Surgical procedures conducted with the aid of computers. This is most frequently used in orthopedic and laparoscopic surgery for implant placement and instrument guidance. Image-guided surgery interactively combines prior CT scans or MRI images with real-time video.
Excision, in part or whole, of an intervertebral disk. The most common indication is disk displacement or herniation. In addition to standard surgical removal, it can be performed by percutaneous diskectomy (DISKECTOMY, PERCUTANEOUS) or by laparoscopic diskectomy, the former being the more common.
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