Skip to main content
OpenTrials
Completed

NCT Number: NCT02368015

Penetration of Cefazolin Into Hepatic Cysts

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology

Nijmegen, Gelderland, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peripheral intravenous cannula (IVC)

Other

Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).

Cefazolin

Drug

Primary outcomes

  1. Hepatic cyst penetration of cefazolin defined as the ratio (%) of cyst aspirate concentration (µg/ml) to serum concentration (µg/ml) of cefazolin.

    Time frame: Intraoperative

Secondary outcomes

  1. Segmental location (I-VIII) of hepatic cyst

    Time frame: Baseline

  2. Volume (mL) of hepatic cyst

    Time frame: Baseline

  3. Blood parameter: total protein (g/l)

    Time frame: Intraoperative

  4. Blood parameter: albumin (g/l)

    Time frame: Intraoperative

  5. Blood parameter: urea (mmol/l)

    Time frame: Intraoperative

  6. Blood parameter: white blood cell count (*10^9/l)

    Time frame: Intraoperative

  7. Blood parameter: white blood differentiation (%)

    Time frame: Intraoperative

  8. Blood parameter: CRP (mg/l)

    Time frame: Intraoperative

  9. Blood parameter: direct bilirubin (µmol/L)

    Time frame: Intraoperative

  10. Blood parameter: total bilirubin (µmol/L)

    Time frame: Intraoperative

  11. Blood parameter: CA 19.9 (E/ml)

    Time frame: Intraoperative

  12. Blood parameter: creatinine (µmol/L)

    Time frame: Intraoperative

  13. Cyst fluid parameter: total protein (g/l)

    Time frame: Intraoperative

  14. Cyst fluid parameter: albumin (g/l)

    Time frame: Intraoperative

  15. Cyst fluid parameter: urea (mmol/l)

    Time frame: Intraoperative

  16. Cyst fluid parameter: white blood cell count (*10^9/l)

    Time frame: Intraoperative

  17. Cyst fluid parameter: white blood cell differentiation (%)

    Time frame: Intraoperative

  18. Cyst fluid parameter: CRP (mg/l)

    Time frame: Intraoperative

  19. Cyst fluid parameter: direct bilirubin (µmol/L)

    Time frame: Intraoperative

  20. Cyst fluid parameter: total bilirubin (µmol/L)

    Time frame: Intraoperative

  21. Cyst fluid parameter: CA 19.9 (E/ml)

    Time frame: Intraoperative

  22. Cyst fluid parameter: sodium (mmol/l)

    Time frame: Intraoperative

  23. Cyst fluid parameter: pH

    Time frame: Intraoperative

  24. Number of patients that develop clinical signs indicating aspiration sclerotherapy-induced cyst infection

    Time frame: Until four weeks after aspiration sclerotherapy

  25. Number of participants with adverse events

    Time frame: until four weeks after aspiration sclerotherapy

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: PENTAC

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 20, 2015
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.