Early Versus Delayed Surgery for Gallstone Pancreatitis (NCT00863642) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Length of hospital stay
Timeframe: Days in the hospital
Trial details
NCT IDNCT00863642
SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center