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

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

Detailed Description
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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.

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

Conditions
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Pancreatitis

Intervention / Treatment
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* Procedure: Early cholecystectomy with IOC
* Procedure: Late cholecystectomy with IOC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early cholecystectomy with IOC<br>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. | Procedure: Early cholecystectomy with IOC<br>* 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.<br>|
| Active Comparator: Late cholecystectomy with IOC<br>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). | Procedure: Late cholecystectomy with IOC<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day hospital length of stay |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from admission to cholecystectomy |  | up to 10 days | 
| Initial hospital LOS |  | up to 30 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, 1 week | 
| 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, 1 week | 
| Change in health-related quality of life as assessed by the standard gamble |  | baseline, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholecystectomy