Acute Biliary Pancreatitis
Conditions
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.
Interventions
PROCEDUREearly cholecystectomy
cholecystectomy was done within 48 after admission
PROCEDUREdelayed cholecystectomy
cholecystectomy was done after 30 days after randomization
Sponsors
Sohag University
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gallstone related complications | 6 month of onset of pancreatitis | recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Gall stones non related complications | up to 6 month | — |
| 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 |
| 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 |
| Length of hospital stay of index admission | from admission to discharge of patient, up to 10 days | — |
Outcome results
None listed