Symptomatic Dominant Liver CystPhase 3SclerocystNCT02048319
Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Hepatic Cysts
A Phase 3 study testing Pasireotide LAR 60 mg and Aspiration sclerotherapy in people with Symptomatic Dominant Liver Cyst, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Liver cysts are fluid filled cavities located in the liver. They are present in 2-11% of the general population, typically not causing any symptoms or complications. However, in a small subset of patients complaints of pain, abdominal fullness and distension, dyspnea and nausea occur. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Symptomatic Dominant Liver Cyst
- What is being tested?
- Pasireotide LAR 60 mg and Aspiration sclerotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2013to Apr 2016
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who are diagnosed with a dominant liver cyst with an indication for aspiration and sclerotherapy are suitable for inclusion in this study.
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age 18 - 70 years
- Indication for aspiration and sclerotherapy
- Providing informed consent
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study
- ASPIRATION SCLEROTHERAPY RELATED EXCLUSION CRITERIA:
- Signs of cyst bleeding on ultrasound
- Signs of cyst infection (elevated CRP and/or leukocytes or temperature exceeding 38 degrees with the exclusion of a different focus)
- Cyst < 5 cm
- Coagulopathy (INR > 2 or platelets < 80 x 10^9)
Show all 26Show fewer
- Severe co-morbidity contraindicating anesthesia (i.e. ASA 4 classification)
- SOMATOSTATIN TREATMENT RELATED EXCLUSION CRITERIA:
- Patients with a known hypersensitivity to SST analogues or any component of the pasireotide LAR or SQ formulations
- Pregnant or nursing women
- Symptomatic cholecystolithiasis
- QT interval related exclusion criteria:
- 9.1 Known (congenital) long QT syndrome or QTcF at screening 470 msec
- 9.2 Family history of long QT syndrome or idiopathic sudden death
- 9.3 Uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure, unstable angina or sustained and/or clinically significant cardiac arrhythmias (e.g. bradycardia)
- 9.4 Risk factors for torsades de pointes: hypokalemia, hypomagnesemia, hypocalcaemia, cardiac failure, clinically significant/symptomatic bradycardia, or high grade AV block
- 9.5 Patients with concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
- 9.6 Taking anti-arrhythmic medicinal products or other substances that are known to lead to QT prolongation
- Uncontrolled diabetes as defined by HbA1C > 64 mmol/ml despite adequate therapy
- History of pancreatitis
- Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment
- FURTHERMORE:
- Use of oral contraception or estrogen supplementation
- Intervention (i.e. aspiration with or without sclerotherapy or surgical intervention) within six months before baseline
- Treatment with somatostatin analogues within six months before baseline
- 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, 6500 HB
About this study
Official title: Assessing Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Dominant Hepatic Cysts: a Randomized, Double-blind, Placebo-controlled Clinical Trial.
Liver cysts are fluid filled cavities located in the liver. They are present in 2-11% of the general population, typically not causing any symptoms or complications. However, in a small subset of patients complaints of pain, abdominal fullness and distension, dyspnea and nausea occur.
Currently, aspiration and sclerotherapy is a treatment of choice in symptomatic patients with a large dominant liver cyst. However, studies reported early fluid reaccumulation and relative high recurrence rates of cyst growth after aspiration sclerotherapy ultimately leading to re-interventions. In this respect, somatostatin analogues are promising agents known for its volume reducing effect in patients with polycystic liver disease.
Read more
In this study the investigators want to evaluate the effect of combining aspiration sclerotherapy with the multi-receptor binding, long-acting somatostatin analogue Pasireotide.
The investigators hypothesize that administrating pasireotide before and after aspiration sclerotherapy could prevent early fluid reaccumulation and thereby result in a greater reduction of cyst diameter. Moreover, the investigators expect a lower rate of cyst recurrence and subsequently lower need for re-interventions.
- Conditions
- Symptomatic Dominant Liver Cyst
- Being tested
- Pasireotide LAR 60 mg, Aspiration sclerotherapy, Placebo
- Keywords
- Liver cyst, Hepatic cyst, Symptomatic, Aspiration sclerotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide LAR 60 mgDrug
Also called Pasireotide long acting release, intramuscular injection
Pasireotide long acting release, intramuscular injection
Aspiration sclerotherapyProcedure or surgery
Also called Drainage with subsequent ethanol instillation
Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation
PlaceboDrug
Also called Saline solution
Saline solution, injected as placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Pasireotide LAR 60 mg | Experimental | The subjects will be randomized (1:1) into two groups. Both groups will undergo aspiration sclerotherapy following the standard procedure. The intervention group will additionally receive two injections of 60 mg pasireotide long-acting release (LAR) intramuscularly: the first injection 14 days before and the second injection 14 days after the intervention. Receives: Drug: Pasireotide LAR 60 mg; Procedure: Aspiration sclerotherapy |
| Placebo | Placebo comparator | Patients in the placebo arm will receive two injections of saline solution corresponding to the scheme of the intervention group. Receives: Procedure: Aspiration sclerotherapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportional diameter change
Proportional change (%) in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.
Measured: 4 weeks
Secondary outcomes (6)
Absolute reduction (cm) hepatic cyst
Absolute change in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.
Measured: 4 weeks
Proportional (%) and absolute cyst reduction (cm) after 12 weeks
Proportional (%) and absolute change in cyst diameter measured by ultrasound 12 weeks after aspiration sclerotherapy.
Measured: 12 weeks
Proportion cyst recurrence
> 80% of its original diameter
Measured: 12 weeks
Symptomatic change and health-related quality of life
Assessment of gastro-intestinal symptoms and health-related quality of life by the GIS- and SF-36 questionnaire respectively
Measured: 4, 12 weeks and 24 weeks
Safety
Any complications or adverse events reported during procedure or follow-up
Measured: At week 2, week 4, week 6, week 14 and week 26 after first Pasireotide injection
Proportional (%) and absolute cyst reduction (cm) after 24 weeks
Long term proportional (%) and absolute change in cyst diameter measured by ultrasound 24 weeks after aspiration sclerotherapy.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Dominant Liver 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 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
- NCT02048319
- Sponsor's protocol ID
- JDTW45115
- Other IDs
- 2013-003168-29
- Acronym
- Sclerocyst
- Status last verified
- May 2016
- First submitted
- 6 Jan 2014
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wijnands TF, Gevers TJ, Kool LJ, Drenth JP. Aspiration sclerotherapy combined with pasireotide to improve reduction of large symptomatic hepatic cysts (SCLEROCYST): study protocol for a randomized controlled trial. Trials. 2015 Mar 7;16:82. doi: 10.1186/s13063-015-0607-3.
PubMed 25873132
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Dominant Hepatic Cysts: a Randomized, Double-blind, Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02048319
- Acronym / sponsor ID
- Sclerocyst / JDTW45115
- Conditions
- Symptomatic Dominant Liver Cyst
- Keywords
- Liver cyst, Hepatic cyst, Symptomatic, Aspiration sclerotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Jan 2014 (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.
Liver cysts are fluid filled cavities located in the liver. They are present in 2-11% of the general population, typically not causing any symptoms or complications. However, in a small subset of patients complaints of pain, abdominal fullness and distension, dyspnea and nausea occur.
Currently, aspiration and sclerotherapy is a treatment of choice in symptomatic patients with a large dominant liver cyst. However, studies reported early fluid reaccumulation and relative high recurrence rates of cyst growth after aspiration sclerotherapy ultimately leading to re-interventions. In this respect, somatostatin analogues are promising agents known for its volume reducing effect in patients with polycystic liver disease.
In this study the investigators want to evaluate the effect of combining aspiration sclerotherapy with the multi-receptor binding, long-acting somatostatin analogue Pasireotide.
The investigators hypothesize that administrating pasireotide before and after aspiration sclerotherapy could prevent early fluid reaccumulation and thereby result in a greater reduction of cyst diameter. Moreover, the investigators expect a lower rate of cyst recurrence and subsequently lower need for re-interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Pasireotide LAR 60 mg | Experimental | Drug: Pasireotide LAR 60 mg, Procedure: Aspiration sclerotherapyThe subjects will be randomized (1:1) into two groups. Both groups will undergo aspiration sclerotherapy following the standard procedure. The intervention group will additionally receive two injections of 60 mg pasireotide long-acting release (LAR) intramuscularly: the first injection 14 days before and the second injection 14 days after the intervention. |
| Placebo | Placebo comparator | Procedure: Aspiration sclerotherapy, Drug: PlaceboPatients in the placebo arm will receive two injections of saline solution corresponding to the scheme of the intervention group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients who are diagnosed with a dominant liver cyst with an indication for aspiration and sclerotherapy are suitable for inclusion in this study.
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age 18 - 70 years
- Indication for aspiration and sclerotherapy
- Providing informed consent
Key exclusion criteria (26 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study
- Signs of cyst bleeding on ultrasound
- Signs of cyst infection (elevated CRP and/or leukocytes or temperature exceeding 38 degrees with the exclusion of a different focus)
- Cyst < 5 cm
- Coagulopathy (INR > 2 or platelets < 80 x 10^9)
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 |
|---|---|---|
| Pasireotide LAR 60 mgAlso: Pasireotide long acting release, intramuscular injectionPasireotide long acting release, intramuscular injection | Drug | Experimental: Pasireotide LAR 60 mg |
| Aspiration sclerotherapyAlso: Drainage with subsequent ethanol instillationPercutaneous drainage of the hepatic cyst with subsequent ethanol instillation | Procedure or surgery | Experimental: Pasireotide LAR 60 mg, Placebo |
| PlaceboAlso: Saline solutionSaline solution, injected as placebo | Drug | Placebo |
Primary outcome
Proportional diameter change
Time frame: 4 weeks
Proportional change (%) in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.
6 secondary outcomes
Absolute reduction (cm) hepatic cyst
Time frame: 4 weeks
Proportional (%) and absolute cyst reduction (cm) after 12 weeks
Time frame: 12 weeks
Proportion cyst recurrence
Time frame: 12 weeks
Symptomatic change and health-related quality of life
Time frame: 4, 12 weeks and 24 weeks
Safety
Time frame: At week 2, week 4, week 6, week 14 and week 26 after first Pasireotide injection
Proportional (%) and absolute cyst reduction (cm) after 24 weeks
Time frame: 24 weeks
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 4 May 2016.
- Derived from this study: PubMed 25873132Wijnands TF, Gevers TJ, Kool LJ, Drenth JP. Aspiration sclerotherapy combined with pasireotide to improve reduction of large symptomatic hepatic cysts (SCLEROCYST): study protocol for a randomized controlled trial. Trials. 2015 Mar 7;16:82. doi: 10.1186/s13063-015-0607-3.
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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 Phase 3 study testing Pasireotide LAR 60 mg and Aspiration sclerotherapy in people with Symptomatic Dominant Liver 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 5 inclusion and 26 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 4 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportional diameter change (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02048319, which also lists 1 linked publication.
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 4 May 2016.