Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis
- Conditions
- Pancreatitis
- Interventions
- Procedure: Early cholecystectomy with IOCProcedure: Late cholecystectomy with IOC
- Registration Number
- NCT02806297
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
-
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.
Exclusion criteria
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early cholecystectomy with IOC Early cholecystectomy with IOC The experimental arm 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. Late cholecystectomy with IOC Late cholecystectomy with IOC The comparator 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).
- Primary Outcome Measures
Name Time Method 30-day hospital length of stay 30 days
- Secondary Outcome Measures
Name Time Method Initial hospital LOS up to 30 days Time from admission to cholecystectomy up to 10 days Number of participants who underwent conversion to open cholecystectomy 30 days Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI) baseline, 1 week Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI) and Patients' Experience of Surgery Questionnaire (PESQ) baseline, 6 weeks Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ) baseline, 6 weeks Change in health-related quality of life as assessed by the standard gamble baseline, 6 weeks
Trial Locations
- Locations (1)
Lyndon B. Johnson General Hospital
🇺🇸Houston, Texas, United States