Early Versus Delayed Surgery for Gallstone Pancreatitis
Gallstone Pancreatitis
About this trial
This is an interventional treatment trial for Gallstone Pancreatitis focused on measuring Early cholecystectomy, gallstone pancreatitis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Harbor-UCLA Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Early
Control
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.
In patients in the control arm, laparoscopic cholecystectomy is delayed until laboratory values normalize and abdominal pain resolves.