The primary objective is to determine the cefazolin penetration into hepatic cysts. Secondary objective are to identify factors affecting antibiotic penetration and to evaluate the association between antibiotic penetration and development of…
ID
Source
Brief title
Condition
- Hepatobiliary disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background 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.
Study objective
The primary objective is to determine the cefazolin penetration into hepatic
cysts. Secondary objective are to identify factors affecting antibiotic
penetration and to evaluate the association between antibiotic penetration and
development of aspiration sclerotherapy-induced cyst infection.
Study design
Explorative study
Study burden and risks
Aspiration sclerotherapy and the accompanying antibiotic prophylaxis with a
single dose of cefazolin (intravenous infusion 1000mg), physical examination,
ultrasonography, and blood samples prior to the procedure are regarded as the
indicated standard of care of dominant symptomatic hepatic cysts. When compared
to aspiration sclerotherapy alone, the burden and risks associated with
participation of this study are:
- possible side effects or adverse events related to the additional peripheral
intravenous line from which we will obtain serum at three time intervals during
the standard of care hospital admission.
- additional withdrawal of blood (approximately 22.5ml) to accurately determine
cefazolin concentration
There is no direct benefit for participants of this study. Future patients
receiving aspiration sclerotherapy could benefit from an improved cyst
infection prophylaxis. Ultimately, leading to a reduced rate of post procedural
cyst infections and therefore resulting in an increased safety of hepatic cyst
interventions.
Geert Grooteplein zuid 8
Nijmegen 6525 GA
NL
Geert Grooteplein zuid 8
Nijmegen 6525 GA
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49426.091.14 |