Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

South Valley University

Status: Completed

Conditions: Acute Biliary Pancreatitis

Treatments: Procedure: early cholecystectomy; Procedure: delayed cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03085407

SVU 148

Details and patient eligibility

About

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.

Full 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

7. 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups

early cholecystectomy

Active Comparator group

Description:

Early cholecystectomy was done within 48 after admission

Treatment:

Procedure: early cholecystectomy

delayed cholecystectomy

Sham Comparator group

Description:

Delayed cholecystectomy was done after 30 days after randomization.

Treatment:

Procedure: delayed cholecystectomy