Cholecystitis From a Microbiological and Histopathological Perspective

April 12, 2024 updated by: Malene Borgager Dissing, Organkirurgisk afdeling, sygehus lillebælt, Kolding
The aim of this project is to investigate the presence of bacteria in the gallbladder wall and the bile in patients undergoing cholecystectomy, to determine if the standard empirical antibiotic treatment used currently is effective against the most common pathogens.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will compare two groups of patients; patients with acute calculous cholecystitis undergoing acute laparoscopic cholecystectomy and patients without cholecystitis undergoing elective laparoscopic cholecystectomy.

Secondly, the investigators wish to investigate if the presence of bacteria correlates with the grade of inflammation, and whether this can predict when cholecystitis is caused by infection.

In a clinical setting, this can provide important knowledge regarding the choice of antibiotics currently used to treat and prevent infection in the gallbladder.

The investigators will conduct two studies, one investigating the bacteria in bile and in the gallbladder wall and the resistens of the bacteria to antibiotics and another study investigating the histopathology of the gallbladder wall to see if the bacteria present is the cause of inflammation or an actual infection.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Kolding, Denmark, 6000
        • Recruiting
        • Sygehus Lillebælt
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The following data will be collected for all included patients:

  • Age
  • Sex
  • Weight
  • Height
  • BMI
  • Smoking
  • Alcohol
  • Diabetes
  • Cardiovascular disease
  • Preoperative blood samples
  • Use of antibiotic within the last year - what type and duration of treatment
  • Number of days with symptoms prior to the cholecystectomy
  • Vitals (blood pressure, pulse, saturation, respiratory rate, temperature)
  • Blood culture prior to the procedure in the case group

Description

Inclusion Criteria:

  • Age above 18 years
  • Signed consent form
  • Patients having cholecystectomy performed at the Department of Surgery, Sygehus Lillebælt, Kolding.

Exclusion Criteria:

  • Administration of any type of antibiotics one month prior to surgery in the control group.
  • Previous instrumentation of the bileducts
  • Previous clinical acute cholecystitis treated conservatively with antibiotics

Patients will be precluded from the studypopulation in cases of pPerioperative perforation of the gallbladder, or conversion to open cholecystectomy or in cases of failed attempts to extract bile or samples from the gallbladder wall.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group

Patients suffering from acute calculous cholecystitis undergoing subacute laparoscopic cholecystectomy.

Samples of bile and gallbladder wall specimens will be taken during surgery and will be sent for microbiological and pathological investigation
Other: Microbiological and histopathological investigation of bile and gallbladder wall specimens.
Bile and gallbladder wall specimens will be taken from all patients included in the study. The material will be sent for microbiological and histopathological investigation.
Control group

Patients suffering from painattacks due to gallstones, who have not symptoms of cholecystitis. The patients will undergo elective laparoscopic cholecystectomy.

Samples of bile and gallbladder wall specimens will be taken during surgery and will be sent for microbiological and pathological investigation
Other: Microbiological and histopathological investigation of bile and gallbladder wall specimens.
Bile and gallbladder wall specimens will be taken from all patients included in the study. The material will be sent for microbiological and histopathological investigation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial colonization in bile and gallbladder wall samples
Time Frame: 36-72 hours

Microbiological investigation of microorganisms present in the bile and in the gallbladder wall.

Bile samples will be collected by puncturing the gallbladder either perioperatively or immediate after extraction of the gallbladder from the abdomen. This is done in a sterile manner using a syringe.

The gallbladder wall specimens are collected immediately after extraction of the gallbladder from the abdomen. Three samples will be taken from macroscopic normal looking parts of the posterior wall in the fundus area using a sterile 4 mm punch biopsy.

Bile samples and punch biopsies sent to the Department of Clinical Microbiology, SLB, will be cultured on selected agar growth media and incubated under aerobic, microaerophilic, and anaerobic conditions.

Bacterial colonies will be identified and quantified using routine laboratory methods.
36-72 hours
Antibiotic resistans
Time Frame: 36-72 hours

Microbiological investigation of antibiotic resistans of the bacteria, if any, present in bile and gallbladder wall specimens.

Antimicrobial susceptibility testing will be performed using the disk diffusion method.

To determine the possible presence of inhibitory concentrations of antibiotics in the bile samples, a droplet of bile from each sample will be added to an agar plate inoculated with the E. coli ATCC 25922-strain. After incubation, the appearance of a growth inhibition zone will be measured.
36-72 hours
Histopathology of the gallbladder
Time Frame: 3-21 days

Histopathological investigation of the gallbladder to investigate if there is either inflammation or an actual infection and correlate these findings to the bacterial colonization.

The gallbladder from all included patients will be sent to the Department of Pathology, SLB, for evaluation of the grade of inflammation.

After formalin fixation sections from the cystic duct, the corpus and the fundus area will be sampled. The sections will be embedded in paraffin and will be cut into thin slices, which will be dyed with hematoxylin and eosin. The grade of acute inflammation will be assessed in a semi quantitative manner:

Grade 1: superficial ulceration of the mucosa concomitant with light infiltration by neutrophile granulocytes Grade 2: infiltration by granulocytes, spreading into the deeper layers of the gallbladder wall.

Grade 3: profound necrosis, extending through the entire gallbladder wall.
3-21 days

Collaborators and Investigators

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

Sponsor

Organkirurgisk afdeling, sygehus lillebælt, Kolding

Investigators

  • Principal Investigator: Malene B Dissing, MD, Organkirurgisk afdeling, sygehus lillebælt, Kolding

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

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)

April 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

February 3, 2023

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBDissing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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