Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis

September 13, 2018 updated by: FRANCISCO RIQUELME, Hospital del Salvador

Early Cholecystectomy in Patients With Mild Gallstone Acute Pancreatitis: A Randomized Prospective Study

Randomized controlled trial to demonstrate the safety of early cholecystectomy (<72h) in patients with mild gallstone pancreatitis. The purpose of this study is to demonstrate that there is a shorter hospital stay and no higher complication rates.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Acute pancreatitis is a prevalent disease, responsible for 220.000 hospital admissions per year in the United States of America. In Chile, during year 2012 there were 76.463 hospital admissions for this diagnosis, with a mean hospital stay of 11,8 days and 25 deaths per year associated with this disease (250 deaths from 2002 to 2012). The most frequent etiology of pancreatitis in Chile is gallstones, which can be present in 80% of the patients admitted for acute pancreatitis. This can be explained by the high prevalence of gallstones among these patients.

Since Acosta and Ledesma demonstrated the association between gallstones and acute pancreatitis in 1974, cholecystectomy has been the most efficient treatment option to prevent recurrence that can reach even 30-40% in the first two weeks after the first episode. There is consensus in delaying the time of the cholecystectomy in patients with acute gallstone pancreatitis where mortality can be as high as 80% in patients presenting with severe cases. However, the vast majority of the patients will present with a mild pancreatitis requiring no more than basic medical support. In these patients, the role of surgery during the same hospital admission has been clearly demonstrated.

There is no current consensus with respect to the safety of performing cholecystectomy in patients with mild pancreatitis within 48 to 72 hours after the hospital admission. There are few well-designed observational studies and only one randomized clinical trial, which has demonstrated a significant decrease in hospital stay (7 to 4 days), without increasing the rate of complications or mortality. According to some models of analysis and decision, this strategy could reduce costs associated with prolonged hospital stays and improve the quality of life of these patients without jeopardizing patient safety.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile
        • Boris Marinkovic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients aged 18-70 years admitted with first gallstone acute pancreatitis (GAP) is evaluated for eligibility. Diagnosis and severity of GAP is based upon Atlanta Consensus modified at 2012. Acute pancreatitis is diagnosed when at least two out of three criteria are met; acute upper abdominal pain, elevated serum amylase/lipase level (more than thrice upper limit of normal range) and evidence of pancreatitis at any imaging modality (abdominal ultrasonography, computed tomography or magnetic resonance image). Biliary etiology is verified by abdominal ultrasonography showing stones or sludge at gallbladder. All other etiologies should be excluded. Exclusions criteria: (1) acute cholecystitis at abdominal ultrasonography, (2) suspected or confirmed acute cholangitis according to 2013 Tokyo Guidelines (fever or laboratory data with inflammatory response, cholestasis and imaging study with biliary dilatation/evident etiology), (3) history of Roux en Y gastric by pass or open supraumbilical surgery, (4) acute alcohol consumption, (5) chronic hepatic/pancreatic disease, (6) comorbidities contraindicating emergency surgery, (7) mental condition that preclude informed consent, (8) pregnancy, (9) patient refusal, (10) no endoscopist availability. There is no exclusions based on choledocolithiasis risk. All patients must complete clinical, anthropometric, and general laboratory/liver function tests at admission and daily until third day of stay or surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early cholecystectomy
Cholecystectomy within the first 72 hours of admission.
Procedure: Early cholecystectomy
Cholecystectomy + intraoperative cholangiography within the first 72 hours of admission.
Other: Control (Delayed cholecystectomy)
Standard care arm. Cholecystectomy is delayed until normalization of laboratory values, abdominal pain resolves and oral intake is restored.
Procedure: Control (Delayed cholecystectomy)
Standard care arm. Cholecystectomy + intraoperative cholangiography is delayed once complete resolution of abdominal tenderness, oral feeding and trending down in pancreatic laboratory is achieved

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay (LOS)
Time Frame: 90 dias
days
90 dias

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic retrograde cholangio-pancreatography (ERCP)
Time Frame: 90 days
yes/no
90 days
Conversion
Time Frame: surgery
yes/no
surgery
Wound infection
Time Frame: 30 days
yes/no
30 days
Re-admission
Time Frame: 90 days
yes/no
90 days
Biliary complications
Time Frame: 90 days
biloma, bile leak, residual choledocholithiasis
90 days
Operative time
Time Frame: surgery
operative time in minutes
surgery
medical complications
Time Frame: 30 days
any medical complication using Clavien-dindo classification
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Salvador

Investigators

  • Principal Investigator: Francisco Riquelme, M.D., Universidad de Chile- Hospital del Salvador

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPPAL-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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