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Penetration of Cefazolin Into Hepatic Cysts

NCT02368015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-02-03

No results posted yet for this study

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.

Conditions

  • Hepatic Cyst

Interventions

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Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).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

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02368015 on ClinicalTrials.gov