Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis

Completed · Not applicable

Conditions studied: Pancreatitis

In brief

Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after resolution of pain for mild gallstone pancreatitis.

Key facts

Study ID

NCT02806297

Run by

The University of Texas Health Science Center, Houston

People needed

100

Starts

2016-06-01

Expected to finish

2018-08-11

Last updated by the study team

2021-03-30

Who can join

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

You may qualify if…

• Diagnosis of gallstone pancreatitis. Patients will be considered to have gallstone pancreatitis if they have:
• upper abdominal pain, nausea, vomiting, and epigastric tenderness
• absence of ethanol abuse
• elevated lipase level above the upper limit of normal (>370 U/L)
• imaging confirmation of gallstones or sludge
• Low predicted mortality using the Bedside Index of Severity in Acute Pancreatitis (BISAP) -Diagnosis of mild pancreatitis (i.e.,no evidence of organ failure or local or systemic complications)
• Scheduled for laparoscopic cholecystectomy prior to discharge
• Lack of any very strong indicator for choledocholithiasis based on the American Society for Gastrointestinal Endoscopy (ASGE) guidelines
• Clinical stability as denoted by admission to a non-monitored floor bed.

You may not qualify if…

• Pregnancy
• Severe preexisting medical comorbidities precluding surgery, organ failure, local or systemic complications of acute pancreatitis
• Chronic pancreatitis
• Native language other than English and Spanish
• Patient refusal to participate

Where it is running

• Lyndon B. Johnson General Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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