Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05549349 - ANGH Prospective Cohort of Mild and Severe Acute Biliary Pancreatitis
Recruiting NCT02668081 - Comparing the Effects of EST and EPBD in Patients With Acute Biliary Pancreatitis N/A
Completed NCT02430285 - Early EUS in Acute Biliary Pancreatitis N/A