Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

NCT ID: NCT03085407

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-01
• Study Completion Date: 2017-12-01

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.

Conditions

Acute Biliary Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

early cholecystectomy

Early cholecystectomy was done within 48 after admission

Group Type: ACTIVE_COMPARATOR

early cholecystectomy

Intervention Type: PROCEDURE

cholecystectomy was done within 48 after admission

delayed cholecystectomy

Delayed cholecystectomy was done after 30 days after randomization.

Group Type: SHAM_COMPARATOR

delayed cholecystectomy

Intervention Type: PROCEDURE

cholecystectomy was done after 30 days after randomization

Interventions

early cholecystectomy

cholecystectomy was done within 48 after admission

Intervention Type: PROCEDURE

delayed cholecystectomy

cholecystectomy was done after 30 days after randomization

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: collaborator

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Ahmed Omar

Lecturer of GIT surgery and laparoendoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SVU 148

Identifier Type: -

Identifier Source: org_study_id