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Trial record 31 of 59 for:    pasireotide

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT02048319
First received: January 6, 2014
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Symptomatic Dominant Liver Cyst
Drug: Pasireotide LAR 60 mg
Procedure: Aspiration sclerotherapy
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Proportional diameter change [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Proportional change (%) in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.


Secondary Outcome Measures:
  • Absolute reduction (cm) hepatic cyst [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Absolute change in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.

  • Proportional (%) and absolute cyst reduction (cm) after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Proportional (%) and absolute change in cyst diameter measured by ultrasound 12 weeks after aspiration sclerotherapy.

  • Proportion cyst recurrence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    > 80% of its original diameter

  • Symptomatic change and health-related quality of life [ Time Frame: 4, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    Assessment of gastro-intestinal symptoms and health-related quality of life by the GIS- and SF-36 questionnaire respectively

  • Safety [ Time Frame: At week 2, week 4, week 6, week 14 and week 26 after first Pasireotide injection ] [ Designated as safety issue: Yes ]
    Any complications or adverse events reported during procedure or follow-up

  • Proportional (%) and absolute cyst reduction (cm) after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Long term proportional (%) and absolute change in cyst diameter measured by ultrasound 24 weeks after aspiration sclerotherapy.


Estimated Enrollment: 34
Study Start Date: December 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02048319

Contacts
Contact: J.P.H Drenth +31243614760 joostphdrenth@cs.com
Contact: T.F.M Wijnands +31650234804 titus.wijnands@radboudumc.nl

Locations
Netherlands
Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Drenth    +31243614760    joostphdrenth@cs.com   
Principal Investigator: Titus FM Wijnands, MD         
Sponsors and Collaborators
Radboud University
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02048319     History of Changes
Other Study ID Numbers: JDTW45115, 2013-003168-29
Study First Received: January 6, 2014
Last Updated: November 5, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Liver cyst
Hepatic cyst
Symptomatic
Aspiration sclerotherapy

Additional relevant MeSH terms:
Cysts
Neoplasms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 20, 2014