Cholecystitis From a Microbiological and Histopathological Perspective

Recruiting

• Conditions: Antibiotic Resistant Infection; Gallbladder Inflammation; Calculous Cholecystitis
• Interventions: Other: Microbiological and histopathological investigation of bile and gallbladder wall specimens.

• Registration Number: NCT05712733
• Lead Sponsor: Organkirurgisk afdeling, sygehus lillebælt, Kolding

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-03
• Study Start: 2023-04-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2025-06
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case group	Microbiological and histopathological investigation of bile and gallbladder wall specimens.	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
Control group	Microbiological and histopathological investigation of bile and gallbladder wall specimens.	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

Primary Outcome Measures

Name	Time	Method
Bacterial colonization in bile and gallbladder wall samples	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.
Antibiotic resistans	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.
Histopathology of the gallbladder	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.

Trial Locations

Locations (1)

Sygehus Lillebælt; 🇩🇰 Kolding, Denmark