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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085407
• Other study ID #: SVU 148
• Status: Completed
• Phase: N/A
• Start date: June 1, 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: September 2018
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Biliary Pancreatitis
• Pancreatitis

Intervention

Procedure:
• early cholecystectomy
cholecystectomy was done within 48 after admission
• delayed cholecystectomy
cholecystectomy was done after 30 days after randomization

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
South Valley University	Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gallstone related complications	recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic	6 month of onset of pancreatitis
Secondary	Difficulty of cholecystectomy	the degree of difficulty of the procedureas assessed by the most experienced surgeon on a 0-10 visual analogue scale	up to 3 hours
Secondary	Conversion to open cholecystectomy		up to 2 hours
Secondary	Operative time	from the begging of the operation to recovery of patient	up to 10 hours
Secondary	Cholecystectomy related complications		up to 1 month
Secondary	additional surgical, endoscopic, or radiological intervention		up to 6 month
Secondary	Gall stones non related complications		up to 6 month
Secondary	Length of hospital stay of index admission		from admission to discharge of patient, up to 10 days
Secondary	Number of readmission		up to 6 month
Secondary	Total length of hospital stay (including readmission)		up to 6 month
Secondary	The number of patient-reported colics irrespective of readmission		up to 6 month
Secondary	Need for intensive care unit admission		up to 6 month
Secondary	Mortality	death from gall stone related complication	up to 6 month