An explorative study determining the hepatic cyst penetration of cefazolin and factors affecting penetration.

Completed

Conditions: Hepatic cyst
liver cyst
post-procedural cyst infection
spontaneous hepatic cyst infection
10019806

Registration Number: NL-OMON41169

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

All patients who are diagnosed with a dominant hepatic cyst and have an indication for aspiration sclerotherapy are suitable for inclusion in this study. The indication for aspiration sclerotherapy is made upon diagnosis of a symptomatic, solitary or dominant simple hepatic cyst, exceeding 5 cm.;In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age >=18 years
- Indication for aspiration and sclerotherapy
- Providing informed consent

Exclusion Criteria

1. Presence of an arteriovenous fistula, history of mastectomy or lymph node dissection at both extremities
2. Signs of phlebitis, defined as localized skin redness and swelling, at both extremities
3. History of cephalosporin and/or penicillin allergy consisting of IgE-mediated reactions as anaphylaxis, angioedema, urticaria.
4. 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 & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is hepatic cyst penetration of cefazolin<br /><br>defined as the ratio (%) of cyst aspirate concentration (µg/ml) to serum<br /><br>concentration (µg/ml) of cefazolin. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are location and volume of the aspirated hepatic<br /><br>cyst, cyst fluid and serum parameters, and development of clinical signs<br /><br>indicating aspiration sclerotherapy-induced cyst infection. </p><br>