Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy
- Conditions
- Acute Biliary Pancreatitis
- Interventions
- Procedure: early cholecystectomyProcedure: delayed cholecystectomy
- Registration Number
- NCT03085407
- Lead Sponsor
- South Valley University
- Brief Summary
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
Inclusion criteria
1. Patient diagnosed with a first attack of mild biliary pancreatitis
2. Age ≥ 18 years
3. American Society of Anesthesiologists (ASA) grade I, II or III
4. a serum C-reactive protein (CRP) concentration less than 100 mg/L,
5. no need for opioid analgesics,
6. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2
- 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
-
- chronic pancreatitis 2. alcohol abuse 3. pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description early cholecystectomy early cholecystectomy Early cholecystectomy was done within 48 after admission delayed cholecystectomy delayed cholecystectomy Delayed cholecystectomy was done after 30 days after randomization.
- Primary Outcome Measures
Name Time Method Gallstone related complications 6 month of onset of pancreatitis recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic
- Secondary Outcome Measures
Name Time Method 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 up to 6 month death from gall stone related complication
Difficulty of cholecystectomy up to 3 hours the degree of difficulty of the procedureas assessed by the most experienced surgeon on a 0-10 visual analogue scale
Conversion to open cholecystectomy up to 2 hours Operative time up to 10 hours from the begging of the operation to recovery of patient
Cholecystectomy related complications up to 1 month additional surgical, endoscopic, or radiological intervention up to 6 month