Lyndon B. Johnson General Hospital
Houston, Texas, 77026, United States
NCT Number: NCT02806297
Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after resolution of pain for mild gallstone pancreatitis.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77026, United States
The purpose of this study is to perform a single-center randomized trial to compare laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) within 24 hours of presentation versus after clinical resolution during index admission for mild gallstone pancreatitis on clinical and patient-reported outcomes. Additionally, this study aims to determine patients' values and preferences that influence decision-making regarding treatment options for gallstone pancreatitis. Hypothesis: During index admission for mild gallstone pancreatitis, early cholecystectomy within 24 hours of presentation regardless of symptoms or laboratory values versus after clinical resolution results in a shorter 30-day total hospital length of stay.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention will be laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) on admission within 24 hours of presentation regardless of whether pain or tenderness are present or laboratory values are elevated.
The control will be laparoscopic cholecystectomy with IOC once the patient has met the following criteria: (a) a score of less than 2 on the Visual Analogue Pain Scale, (b) no tenderness on physical exam, and (c) decreased lipase to either less than half of the peak value or within normal range (73-393 U/L).
Time frame: 30 days
Time frame: up to 10 days
Time frame: up to 30 days
Time frame: 30 days
Time frame: baseline, 1 week
Time frame: baseline, 6 weeks
Time frame: baseline, 1 week
Time frame: baseline, 6 weeks
Time frame: baseline, 1 week
Time frame: baseline, 6 weeks
The University of Texas Health Science Center, Houston
Other
A Randomized Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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