Early Versus Delayed Surgery for Gallstone Pancreatitis
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|ClinicalTrials.gov Identifier: NCT00863642|
Recruitment Status : Completed
First Posted : March 18, 2009
Last Update Posted : September 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gallstone Pancreatitis||Procedure: Laparoscopic cholecystectomy within 48 hours of admission Procedure: Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Versus Delayed Surgery for Gallstone Pancreatitis: A Prospective Randomized|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
In patients who present with mild to moderate gallstone pancreatitis, those randomized to the early arm will undergo laparoscopic cholecystectomy within 48 hours of admission, regardless of laboratory values normalization and resolution of abdominal pain.
Procedure: Laparoscopic cholecystectomy within 48 hours of admission
Patients are taken to the operating room for laparoscopic cholecystectomy within 48 hours of admission
In patients in the control arm, laparoscopic cholecystectomy is delayed until laboratory values normalize and abdominal pain resolves.
Procedure: Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values
Patients are taken to the operating room for laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values
- Length of hospital stay [ Time Frame: Days in the hospital ]
- Rates of conversion to open surgery, complication rates and rates of need for endoscopic retrograde cholangiogram [ Time Frame: Within 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863642
|United States, California|
|Harbor-UCLA Medical Center|
|Torrance, California, United States, 90509|