Hepatic Cyst
Conditions
Keywords
Penetration, Cefazolin, Hepatic cyst
Brief summary
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.
Interventions
OTHERPeripheral intravenous cannula (IVC)
Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).
DRUGcefazolin
Sponsors
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Segmental location (I-VIII) of hepatic cyst | Baseline |
| Volume (mL) of hepatic cyst | Baseline |
| Cyst fluid parameter: white blood cell differentiation (%) | 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 |
| 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 |
| Blood parameter: total protein (g/l) | Intraoperative |
Countries
Netherlands
Outcome results
None listed