Clinical trial NCT02368015: Penetration of Cefazolin Into Hepatic Cysts
Official title: An Explorative Study Determining the Hepatic Cyst Penetration of Cefazolin and Factors Affecting Penetration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Cyst
Keywords: Penetration
Cefazolin
Hepatic cyst
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hepatic cyst penetration of cefazolin defined as the ratio (%) of cyst aspirate concentration (µg/ml) to serum concentration (µg/ml) of cefazolin.
timeFrame: Intraoperative
Secondary outcomes:
measure: Segmental location (I-VIII) of hepatic cyst
timeFrame: Baseline
measure: Volume (mL) of hepatic cyst
timeFrame: Baseline
measure: Blood parameter: total protein (g/l)
timeFrame: Intraoperative
measure: Blood parameter: albumin (g/l)
timeFrame: Intraoperative
measure: Blood parameter: urea (mmol/l)
timeFrame: Intraoperative
measure: Blood parameter: white blood cell count (*10^9/l)
timeFrame: Intraoperative
measure: Blood parameter: white blood differentiation (%)
timeFrame: Intraoperative
measure: Blood parameter: CRP (mg/l)
timeFrame: Intraoperative
measure: Blood parameter: direct bilirubin (µmol/L)
timeFrame: Intraoperative
measure: Blood parameter: total bilirubin (µmol/L)
timeFrame: Intraoperative
measure: Blood parameter: CA 19.9 (E/ml)
timeFrame: Intraoperative
measure: Blood parameter: creatinine (µmol/L)
timeFrame: Intraoperative
measure: Cyst fluid parameter: total protein (g/l)
timeFrame: Intraoperative
measure: Cyst fluid parameter: albumin (g/l)
timeFrame: Intraoperative
measure: Cyst fluid parameter: urea (mmol/l)
timeFrame: Intraoperative
measure: Cyst fluid parameter: white blood cell count (*10^9/l)
timeFrame: Intraoperative
measure: Cyst fluid parameter: white blood cell differentiation (%)
timeFrame: Intraoperative
measure: Cyst fluid parameter: CRP (mg/l)
timeFrame: Intraoperative
measure: Cyst fluid parameter: direct bilirubin (µmol/L)
timeFrame: Intraoperative
measure: Cyst fluid parameter: total bilirubin (µmol/L)
timeFrame: Intraoperative
measure: Cyst fluid parameter: CA 19.9 (E/ml)
timeFrame: Intraoperative
measure: Cyst fluid parameter: sodium (mmol/l)
timeFrame: Intraoperative
measure: Cyst fluid parameter: pH
timeFrame: Intraoperative
measure: Number of patients that develop clinical signs indicating aspiration sclerotherapy-induced cyst infection
timeFrame: Until four weeks after aspiration sclerotherapy
measure: Number of participants with adverse events
timeFrame: until four weeks after aspiration sclerotherapy
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology
state: Gelderland
Study officials:
References: