NCT02806297

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pancreatitis

Interventions

Type	Name	Description
PROCEDURE	Early cholecystectomy with IOC	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.
PROCEDURE	Late cholecystectomy with IOC	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).

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-06-28
• Completion: 2018-08-11
• First posted: 2016-06-20
• Last updated: 2021-03-30

Locations

1 site across 1 country: United States