Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy

Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy: A Prospective Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Biliary Pancreatitis
• Intervention / Treatment: Procedure: early cholecystectomy; Procedure: delayed cholecystectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: early cholecystectomy; Early cholecystectomy was done within 48 after admission	Procedure: early cholecystectomy; cholecystectomy was done within 48 after admission
SHAM_COMPARATOR: delayed cholecystectomy; Delayed cholecystectomy was done after 30 days after randomization.	Procedure: delayed cholecystectomy; cholecystectomy was done after 30 days after randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gallstone related complications	recurrent pancreatitis, cholecystitis, cholangitis, obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography, or gallstone colic	6 month of onset of pancreatitis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Conversion to open cholecystectomy		up to 2 hours
Operative time	from the begging of the operation to recovery of patient	up to 10 hours
Cholecystectomy related complications		up to 1 month
additional surgical, endoscopic, or radiological intervention		up to 6 month
Gall stones non related complications		up to 6 month
Length of hospital stay of index admission		from admission to discharge of patient, up to 10 days
Number of readmission		up to 6 month
Total length of hospital stay (including readmission)		up to 6 month
The number of patient-reported colics irrespective of readmission		up to 6 month
Need for intensive care unit admission		up to 6 month
Mortality	death from gall stone related complication	up to 6 month

Collaborators and Investigators

• Sponsor: South Valley University
• Collaborators: Sohag University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2014
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: March 19, 2017
• First Submitted That Met QC Criteria: March 19, 2017
• First Posted (ACTUAL): March 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: SVU 148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No