Hepatic CystPENTACNCT02368015
Penetration of Cefazolin Into Hepatic Cysts
A study testing Peripheral intravenous cannula (IVC) and cefazolin in people with Hepatic Cyst, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Cyst
- What is being tested?
- Peripheral intravenous cannula (IVC) and cefazolin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Indication for aspiration and sclerotherapy
- Providing informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology
Nijmegen, Gelderland, 6500 HB
About this study
Official title: An Explorative Study Determining the Hepatic Cyst Penetration of Cefazolin and Factors Affecting Penetration.
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
- Being tested
- Peripheral intravenous cannula (IVC), cefazolin
- Keywords
- Penetration, Cefazolin, Hepatic cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral intravenous cannula (IVC)Other
Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).
cefazolinDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients with a large hepatic cyst | Other | During this study all subjects undergo aspiration sclerotherapy and receive antibiotic prophylaxis with a single dose of cefazolin (intravenous infusion 1000mg) following standard care.
In order to secure patient safety and allow accurate measurement of cefazolin concentrations, an additional peripheral intravenous cannula (IVC) will be placed to allow blood withdrawal at three timepoints. Receives: Other: Peripheral intravenous cannula (IVC); Drug: cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic cyst penetration of cefazolin defined as the ratio (%) of cyst aspirate concentration (µg/ml) to serum concentration (µg/ml) of cefazolin.
Measured: Intraoperative
Secondary outcomes (25)
Segmental location (I-VIII) of hepatic cyst
Measured: Baseline
Volume (mL) of hepatic cyst
Measured: Baseline
Blood parameter: total protein (g/l)
Measured: Intraoperative
Blood parameter: albumin (g/l)
Measured: Intraoperative
Blood parameter: urea (mmol/l)
Measured: Intraoperative
Blood parameter: white blood cell count (*10^9/l)
Measured: Intraoperative
Blood parameter: white blood differentiation (%)
Measured: Intraoperative
Blood parameter: CRP (mg/l)
Measured: Intraoperative
Blood parameter: direct bilirubin (µmol/L)
Measured: Intraoperative
Blood parameter: total bilirubin (µmol/L)
Measured: Intraoperative
Blood parameter: CA 19.9 (E/ml)
Measured: Intraoperative
Blood parameter: creatinine (µmol/L)
Measured: Intraoperative
Cyst fluid parameter: total protein (g/l)
Measured: Intraoperative
Cyst fluid parameter: albumin (g/l)
Measured: Intraoperative
Cyst fluid parameter: urea (mmol/l)
Measured: Intraoperative
Cyst fluid parameter: white blood cell count (*10^9/l)
Measured: Intraoperative
Cyst fluid parameter: white blood cell differentiation (%)
Measured: Intraoperative
Cyst fluid parameter: CRP (mg/l)
Measured: Intraoperative
Cyst fluid parameter: direct bilirubin (µmol/L)
Measured: Intraoperative
Cyst fluid parameter: total bilirubin (µmol/L)
Measured: Intraoperative
Cyst fluid parameter: CA 19.9 (E/ml)
Measured: Intraoperative
Cyst fluid parameter: sodium (mmol/l)
Measured: Intraoperative
Cyst fluid parameter: pH
Measured: Intraoperative
Number of patients that develop clinical signs indicating aspiration sclerotherapy-induced cyst infection
Measured: Until four weeks after aspiration sclerotherapy
Number of participants with adverse events
Measured: until four weeks after aspiration sclerotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CystStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368015
- Sponsor's protocol ID
- NL49426.091.14
- Acronym
- PENTAC
- Status last verified
- Feb 2016
- First submitted
- 29 Dec 2014
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Study Determining the Hepatic Cyst Penetration of Cefazolin and Factors Affecting Penetration.
- ClinicalTrials.gov ID
- NCT02368015
- Acronym / sponsor ID
- PENTAC / NL49426.091.14
- Conditions
- Hepatic Cyst
- Keywords
- Penetration, Cefazolin, Hepatic cyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a large hepatic cyst | Other | Other: Peripheral intravenous cannula (IVC), Drug: cefazolinDuring this study all subjects undergo aspiration sclerotherapy and receive antibiotic prophylaxis with a single dose of cefazolin (intravenous infusion 1000mg) following standard care. In order to secure patient safety and allow accurate measurement of cefazolin concentrations, an additional peripheral intravenous cannula (IVC) will be placed to allow blood withdrawal at three timepoints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Indication for aspiration and sclerotherapy
- Providing informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral intravenous cannula (IVC)Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC). | Other | Patients with a large hepatic cyst |
| cefazolin | Drug | Patients with a large hepatic cyst |
Primary outcome
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
25 secondary outcomes
Segmental location (I-VIII) of hepatic cyst
Time frame: Baseline
Volume (mL) of hepatic cyst
Time frame: Baseline
Blood parameter: total protein (g/l)
Time frame: Intraoperative
Blood parameter: albumin (g/l)
Time frame: Intraoperative
Blood parameter: urea (mmol/l)
Time frame: Intraoperative
Blood parameter: white blood cell count (*10^9/l)
Time frame: Intraoperative
Blood parameter: white blood differentiation (%)
Time frame: Intraoperative
Blood parameter: CRP (mg/l)
Time frame: Intraoperative
Blood parameter: direct bilirubin (µmol/L)
Time frame: Intraoperative
Blood parameter: total bilirubin (µmol/L)
Time frame: Intraoperative
Blood parameter: CA 19.9 (E/ml)
Time frame: Intraoperative
Blood parameter: creatinine (µmol/L)
Time frame: Intraoperative
Cyst fluid parameter: total protein (g/l)
Time frame: Intraoperative
Cyst fluid parameter: albumin (g/l)
Time frame: Intraoperative
Cyst fluid parameter: urea (mmol/l)
Time frame: Intraoperative
Cyst fluid parameter: white blood cell count (*10^9/l)
Time frame: Intraoperative
Cyst fluid parameter: white blood cell differentiation (%)
Time frame: Intraoperative
Cyst fluid parameter: CRP (mg/l)
Time frame: Intraoperative
Cyst fluid parameter: direct bilirubin (µmol/L)
Time frame: Intraoperative
Cyst fluid parameter: total bilirubin (µmol/L)
Time frame: Intraoperative
Cyst fluid parameter: CA 19.9 (E/ml)
Time frame: Intraoperative
Cyst fluid parameter: sodium (mmol/l)
Time frame: Intraoperative
Cyst fluid parameter: pH
Time frame: Intraoperative
Number of patients that develop clinical signs indicating aspiration sclerotherapy-induced cyst infection
Time frame: Until four weeks after aspiration sclerotherapy
Number of participants with adverse events
Time frame: until four weeks after aspiration sclerotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral intravenous cannula (IVC) and cefazolin in people with Hepatic Cyst, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.