Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

Acute Biliary Pancreatitis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Biliary Pancreatitis
• Pancreatitis

• NCT number: NCT03085407
• Study type: Interventional
• Source: South Valley University
• Status: Completed
• Phase: N/A
• Start date: June 1, 2014
• Completion date: December 1, 2017