Penetration of Cefazolin Into Hepatic Cysts (PENTAC)

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Cyst
• Intervention / Treatment: Other: Peripheral intravenous cannula (IVC); Drug: cefazolin

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Patients with a large hepatic cyst; 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); Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).; Drug: cefazolin

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: December 29, 2014
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (ESTIMATE): February 20, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2016
• Last Update Submitted That Met QC Criteria: February 2, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Penetration; Cefazolin; Hepatic cyst
• Additional Relevant MeSH Terms: Neoplasms; Pathological Conditions, Anatomical; Cysts; Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: NL49426.091.14