MedPath

Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

Not Applicable
Completed
Conditions
Acute Biliary Pancreatitis
Interventions
Procedure: early cholecystectomy
Procedure: 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
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
Read More
Exclusion Criteria
    1. chronic pancreatitis 2. alcohol abuse 3. pregnancy
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
early cholecystectomyearly cholecystectomyEarly cholecystectomy was done within 48 after admission
delayed cholecystectomydelayed cholecystectomyDelayed cholecystectomy was done after 30 days after randomization.
Primary Outcome Measures
NameTimeMethod
Gallstone related complications6 month of onset of pancreatitis

recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic

Secondary Outcome Measures
NameTimeMethod
Gall stones non related complicationsup to 6 month
Length of hospital stay of index admissionfrom admission to discharge of patient, up to 10 days
Number of readmissionup to 6 month
Total length of hospital stay (including readmission)up to 6 month
The number of patient-reported colics irrespective of readmissionup to 6 month
Need for intensive care unit admissionup to 6 month
Mortalityup to 6 month

death from gall stone related complication

Difficulty of cholecystectomyup 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 cholecystectomyup to 2 hours
Operative timeup to 10 hours

from the begging of the operation to recovery of patient

Cholecystectomy related complicationsup to 1 month
additional surgical, endoscopic, or radiological interventionup to 6 month
© Copyright 2025. All Rights Reserved by MedPath