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Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Hepatic Cysts (Sclerocyst)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02048319
Recruitment Status : Completed
First Posted : January 29, 2014
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Symptomatic Dominant Liver Cyst Drug: Pasireotide LAR 60 mg Procedure: Aspiration sclerotherapy Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : December 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Pasireotide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Pasireotide LAR 60 mg
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.
 Drug: Pasireotide LAR 60 mg
Pasireotide long acting release, intramuscular injection
Other Name: Pasireotide long acting release, intramuscular injection

Procedure: Aspiration sclerotherapy
Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation
Other Name: Drainage with subsequent ethanol instillation
Placebo Comparator: Placebo
Patients in the placebo arm will receive two injections of saline solution corresponding to the scheme of the intervention group.
 Procedure: Aspiration sclerotherapy
Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation
Other Name: Drainage with subsequent ethanol instillation

Drug: Placebo
Saline solution, injected as placebo
Other Name: Saline solution


Outcome Measures
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Primary Outcome Measures :
  1. Proportional diameter change [ Time Frame: 4 weeks ]
    Proportional change (%) in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.


Secondary Outcome Measures :
  1. Absolute reduction (cm) hepatic cyst [ Time Frame: 4 weeks ]
    Absolute change in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.

  2. Proportional (%) and absolute cyst reduction (cm) after 12 weeks [ Time Frame: 12 weeks ]
    Proportional (%) and absolute change in cyst diameter measured by ultrasound 12 weeks after aspiration sclerotherapy.

  3. Proportion cyst recurrence [ Time Frame: 12 weeks ]
    > 80% of its original diameter

  4. Symptomatic change and health-related quality of life [ Time Frame: 4, 12 weeks and 24 weeks ]
    Assessment of gastro-intestinal symptoms and health-related quality of life by the GIS- and SF-36 questionnaire respectively

  5. Safety [ Time Frame: At week 2, week 4, week 6, week 14 and week 26 after first Pasireotide injection ]
    Any complications or adverse events reported during procedure or follow-up

  6. Proportional (%) and absolute cyst reduction (cm) after 24 weeks [ Time Frame: 24 weeks ]
    Long term proportional (%) and absolute change in cyst diameter measured by ultrasound 24 weeks after aspiration sclerotherapy.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study

ASPIRATION SCLEROTHERAPY RELATED EXCLUSION CRITERIA:

  1. Signs of cyst bleeding on ultrasound
  2. Signs of cyst infection (elevated CRP and/or leukocytes or temperature exceeding 38 degrees with the exclusion of a different focus)
  3. Cyst < 5 cm
  4. Coagulopathy (INR > 2 or platelets < 80 x 10^9)

  5. Severe co-morbidity contraindicating anesthesia (i.e. ASA 4 classification)

    SOMATOSTATIN TREATMENT RELATED EXCLUSION CRITERIA:

  6. Patients with a known hypersensitivity to SST analogues or any component of the pasireotide LAR or SQ formulations
  7. Pregnant or nursing women
  8. Symptomatic cholecystolithiasis

  9. 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
  10. Uncontrolled diabetes as defined by HbA1C > 64 mmol/ml despite adequate therapy
  11. History of pancreatitis

  12. Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment

    FURTHERMORE:

  13. Use of oral contraception or estrogen supplementation
  14. Intervention (i.e. aspiration with or without sclerotherapy or surgical intervention) within six months before baseline
  15. Treatment with somatostatin analogues within six months before baseline
  16. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048319


Locations
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Netherlands
Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT02048319    
Other Study ID Numbers: JDTW45115
2013-003168-29 ( EudraCT Number )
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016
Keywords provided by Radboud University Medical Center:
Liver cyst
Hepatic cyst
Symptomatic
Aspiration sclerotherapy
Additional relevant MeSH terms:
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Cysts
Neoplasms
Pathological Conditions, Anatomical
Ethanol
Pasireotide
Anti-Infective Agents, Local
 Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists