CompletedNot Applicable

Early Versus Delayed Surgery for Gallstone Pancreatitis

United States100 participantsStarted 2007-11

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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).

What they're measuring

Length of hospital stay

Timeframe: Days in the hospital

Trial details

NCT IDNCT00863642

SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

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