Status:
COMPLETED
Early Versus Delayed Surgery for Gallstone Pancreatitis
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborating Sponsors:
University of California, Los Angeles
Conditions:
Gallstone Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- All adults are included between the age of 18 and 100 with mild to moderate gallstone pancreatitis.
- A subject is classified as having gallstone pancreatitis if they had the following:
- upper abdominal pain, nausea, vomiting and epigastric tenderness;
- absence of ethanol abuse;
- elevated amylase level to at least twice the upper limit of normal and elevated lipase level to at lease three times the upper limit of normal; and
- imaging confirmation of gallstones.
- The classification of mild to moderate pancreatitis is defined by the presence of the following:
- three or fewer Ranson's criteria on admission: age \> 55 years, glucose \> 200 mg/dL , LDH\> 350 mg/dL, AST \> 250 units/L, and WBC\>16 K/mm3;
- clinical stability with admission to a non-monitored ward bed;
- absence of acute cholangitis: defined as a temperature \>38.6°C, right upper quadrant pain and tenderness, and significant hyperbilirubinemia; and
- low suspicion for a retained common bile duct (CBD) stone (total bilirubin \<4 mg/dl on admission).
Exclusion
- Severe pancreatitis (as defined by the presence of more than three Ranson's criteria on admission);
- Suspected concomitant acute cholangitis;
- High suspicion for retained common bile duct stone (total bilirubin ≥ 4 mg/dl on admission or ultrasound demonstration of CBD stone);
- Patient refusal to participate;
- Severe preexisting medical comorbidities contraindicating cholecystectomy (as determined by the primary physicians);
- Pregnancy,
- Prior gastric bypass surgery (making ERC difficult )
- Admission to a monitored unit. The need for admission to a monitored bed is determined by the admitting surgeon and is guided primarily by a need for aggressive fluid administration as demonstrated by severe volume depletion (e.g., admission tachycardia \>110 beats/minute, blood urea nitrogen \> 15 mg/dl) or evidence of cholangitis.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00863642
Start Date
November 1 2007
End Date
November 1 2009
Last Update
September 27 2011
Active Locations (1)
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1
Harbor-UCLA Medical Center
Torrance, California, United States, 90509