Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

Study Overview
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Brief Summary
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In patients with mild gallstone pancreatitis, early cholecystectomy within 48 hours might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy in our locality of conservative management and delayed cholecystectomy. However, evidence to support early cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare the benefits and harms of early versus delayed cholecystectomy in patients with mild biliary pancreatitis.

Detailed Description
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Inclusion criteria Patient diagnosed with a first attack of mild biliary pancreatitis Age ≥ 18 years American Society of Anesthesiologists (ASA) grade I, II or III a serum C-reactive protein (CRP) concentration less than 100 mg/L, no need for opioid analgesics, normal oral diet tolerance Exclusion criteria 1. chronic pancreatitis 2. alcohol abuse 3. pregnancy The number of patients needed was calculated. Considering a power of 80% and reliability of 0.05, we found that 53 patients should be present in each group. Eligible patients will be randomly divided into two equal groups (Group 1: early cholecystectomy, Group 2: delayed cholecystectomy) according to a computer-generated random numbers. Procedure Early cholecystectomy was done within 48 after admission. Delayed cholecystectomy was done after 30 days after randomization. All cholecystectomies were done by, or under the direct supervision of, a surgeon who had undertaken at least 100 cholecystectomies in the past 5 years.

Official Title
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Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy: A Prospective Randomized Study

Conditions
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Acute Biliary Pancreatitis

Intervention / Treatment
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* Procedure: early cholecystectomy
* Procedure: delayed cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient diagnosed with a first attack of mild biliary pancreatitis Age ≥ 18 years American Society of Anesthesiologists (ASA) grade I, II or III a serum C-reactive protein (CRP) concentration less than 100 mg/L, no need for opioid analgesics, normal oral diet tolerance Exclusion Criteria: 1. chronic pancreatitis 2. alcohol abuse 3. pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: early cholecystectomy<br>Early cholecystectomy was done within 48 after admission | Procedure: early cholecystectomy<br>* cholecystectomy was done within 48 after admission<br>|
| Sham Comparator: delayed cholecystectomy<br>Delayed cholecystectomy was done after 30 days after randomization. | Procedure: delayed cholecystectomy<br>* cholecystectomy was done after 30 days after randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gallstone related complications | recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic | 6 month of onset of pancreatitis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulty of cholecystectomy | the degree of difficulty of the procedureas assessed by the most experienced surgeon on a 0-10 visual analogue scale | up to 3 hours | 
| Conversion to open cholecystectomy |  | up to 2 hours | 
| Operative time | from the begging of the operation to recovery of patient | up to 10 hours | 
| Cholecystectomy related complications |  | up to 1 month | 
| additional surgical, endoscopic, or radiological intervention |  | up to 6 month | 
| Gall stones non related complications |  | up to 6 month | 
| Length of hospital stay of index admission |  | from admission to discharge of patient, up to 10 days | 
| Number of readmission |  | up to 6 month | 
| Total length of hospital stay (including readmission) |  | up to 6 month | 
| The number of patient-reported colics irrespective of readmission |  | up to 6 month | 
| Need for intensive care unit admission |  | up to 6 month | 
| Mortality | death from gall stone related complication | up to 6 month |