Early Versus Delayed Surgery for Gallstone Pancreatitis

Completed · Not applicable

Conditions studied: Gallstone Pancreatitis

In brief

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.

Key facts

Study ID

NCT00863642

Run by

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

People needed

100

Starts

2007-11-01

Expected to finish

2009-11-01

Last updated by the study team

2011-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Harbor-UCLA Medical Center — Torrance, California, United States

Full record on ClinicalTrials.gov

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