Clinical trial NCT03085407: Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy
Official title: Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Biliary Pancreatitis
Lead sponsor: South Valley University
Sponsor class: OTHER
Collaborators: name: Sohag University
First posted: 2017-03-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gallstone related complications
timeFrame: 6 month of onset of pancreatitis
Secondary outcomes:
measure: Difficulty of cholecystectomy
timeFrame: up to 3 hours
measure: Conversion to open cholecystectomy
timeFrame: up to 2 hours
measure: Operative time
timeFrame: up to 10 hours
measure: Cholecystectomy related complications
timeFrame: up to 1 month
measure: additional surgical, endoscopic, or radiological intervention
timeFrame: up to 6 month
measure: Gall stones non related complications
timeFrame: up to 6 month
measure: Length of hospital stay of index admission
timeFrame: from admission to discharge of patient, up to 10 days
measure: Number of readmission
timeFrame: up to 6 month
measure: Total length of hospital stay (including readmission)
timeFrame: up to 6 month
measure: The number of patient-reported colics irrespective of readmission
timeFrame: up to 6 month
measure: Need for intensive care unit admission
timeFrame: up to 6 month
measure: Mortality
timeFrame: up to 6 month
Other outcomes:
Locations:
Study officials:
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