Penetration of Cefazolin Into Hepatic Cysts

Study Overview
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Brief Summary
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Hepatic cysts are fluid-filled cavities located in the liver parenchyma. They are usually asymptomatic, but can cause mass-related symptoms as abdominal pain, dyspnea and nausea. Aspiration sclerotherapy is indicated in patients with a dominant hepatic cyst to alleviate symptoms by draining the hepatic cyst to reduce cyst diameter. Spontaneous cyst infection, or following aspiration sclerotherapy, presents a severe complication of hepatic cystic disease requiring frequent hospitalization, long-term antibiotic treatment, and in some invasive therapies. Evidence that antibiotics are able to reach adequate intracystic concentration is however lacking. To prevent procedure-related cyst infection in patients receiving aspiration sclerotherapy, cefazolin prophylaxis is given as standard of care. In this study we want to assess the hepatic cyst penetration capacity of cefazolin by comparing serum and cyst fluid concentrations of cefazolin. We hypothesize that cefazolin is able to penetrate hepatic cysts, with treatment naïve cyst allowing a better penetration, reducing the risk of developing cyst infection following aspiration sclerotherapy.

Official Title
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An Explorative Study Determining the Hepatic Cyst Penetration of Cefazolin and Factors Affecting Penetration.

Conditions
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Hepatic Cyst

Intervention / Treatment
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* Other: Peripheral intravenous cannula (IVC)
* Drug: cefazolin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Indication for aspiration and sclerotherapy Providing informed consent Exclusion Criteria: Presence of an arteriovenous fistula, history of mastectomy or lymph node dissection at both extremities Signs of phlebitis, defined as localized skin redness and swelling, at both extremities History of cephalosporin and/or penicillin allergy consisting of IgE-mediated reactions as anaphylaxis, angioedema, urticaria. Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with a large hepatic cyst<br>During this study all subjects undergo aspiration sclerotherapy and receive antibiotic prophylaxis with a single dose of cefazolin (intravenous infusion 1000mg) following standard care. In order to secure patient safety and allow accurate measurement of cefazolin concentrations, an additional peripheral intravenous cannula (IVC) will be placed to allow blood withdrawal at three timepoints. | Other: Peripheral intravenous cannula (IVC)<br>* Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).<br>Drug: cefazolin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic cyst penetration of cefazolin defined as the ratio (%) of cyst aspirate concentration (µg/ml) to serum concentration (µg/ml) of cefazolin. |  | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Segmental location (I-VIII) of hepatic cyst |  | Baseline | 
| Volume (mL) of hepatic cyst |  | Baseline | 
| Blood parameter: total protein (g/l) |  | Intraoperative | 
| Blood parameter: albumin (g/l) |  | Intraoperative | 
| Blood parameter: urea (mmol/l) |  | Intraoperative | 
| Blood parameter: white blood cell count (*10^9/l) |  | Intraoperative | 
| Blood parameter: white blood differentiation (%) |  | Intraoperative | 
| Blood parameter: CRP (mg/l) |  | Intraoperative | 
| Blood parameter: direct bilirubin (µmol/L) |  | Intraoperative | 
| Blood parameter: total bilirubin (µmol/L) |  | Intraoperative | 
| Blood parameter: CA 19.9 (E/ml) |  | Intraoperative | 
| Blood parameter: creatinine (µmol/L) |  | Intraoperative | 
| Cyst fluid parameter: total protein (g/l) |  | Intraoperative | 
| Cyst fluid parameter: albumin (g/l) |  | Intraoperative | 
| Cyst fluid parameter: urea (mmol/l) |  | Intraoperative | 
| Cyst fluid parameter: white blood cell count (*10^9/l) |  | Intraoperative | 
| Cyst fluid parameter: white blood cell differentiation (%) |  | Intraoperative | 
| Cyst fluid parameter: CRP (mg/l) |  | Intraoperative | 
| Cyst fluid parameter: direct bilirubin (µmol/L) |  | Intraoperative | 
| Cyst fluid parameter: total bilirubin (µmol/L) |  | Intraoperative | 
| Cyst fluid parameter: CA 19.9 (E/ml) |  | Intraoperative | 
| Cyst fluid parameter: sodium (mmol/l) |  | Intraoperative | 
| Cyst fluid parameter: pH |  | Intraoperative | 
| Number of patients that develop clinical signs indicating aspiration sclerotherapy-induced cyst infection |  | Until four weeks after aspiration sclerotherapy | 
| Number of participants with adverse events |  | until four weeks after aspiration sclerotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Penetration, Cefazolin, Hepatic cyst