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

An explorative study determining the hepatic cyst penetration of cefazolin and factors affecting penetration. - PENTAC: PENeTration of the Antibiotic Cefazolin into hepatic cysts

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41169
Enrollment
9
Registered
2014-12-22
Start date
2015-02-26
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic cyst liver cyst post-procedural cyst infection spontaneous hepatic cyst infection

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is hepatic cyst penetration of cefazolin defined as the ratio (%) of cyst aspirate concentration (µg/ml) to serum concentration (µg/ml) of cefazolin.

Secondary

MeasureTime frame
Secondary study parameters are location and volume of the aspirated hepatic cyst, cyst fluid and serum parameters, and development of clinical signs indicating aspiration sclerotherapy-induced cyst infection.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)