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Trial · Interventional

CompletedPhase 3Registry data

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

Short name Sclerocyst

NCTNCT02048319 (opens ClinicalTrials.gov in a new tab)Other idJDTW45115Other id2013-003168-29
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
34 participants (actual)
Sponsor
Radboud University Medical Center · Other
Design
Randomized · Quadruple masking
Countries
1 country

Netherlands

Start
Dec 2013
Primary completion
Nov 2015
Completion
Apr 2016
First posted
29 Jan 2014 (estimated)
Last update posted
4 May 2016 (estimated)
Conditions
Symptomatic Dominant Liver Cyst

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph 3

    Sclerocyst

    NCT02048319

    Dec 2013 to Apr 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Pasireotide LAR 60 mgDrug
  • Aspiration sclerotherapyProcedure
  • PlaceboDrug

Arms2

  • 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.

  • Placebo comparator

    Placebo

    Patients in the placebo arm will receive two injections of saline solution corresponding to the scheme of the intervention group.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proportional diameter change

    Time frame · 4 weeks

    Registry description

    Proportional change (%) in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.

Secondary outcomes(6)

  1. Absolute reduction (cm) hepatic cyst

    Time frame · 4 weeks

    Registry description

    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

    Registry description

    Proportional (%) and absolute change in cyst diameter measured by ultrasound 12 weeks after aspiration sclerotherapy.

  3. Proportion cyst recurrence

    Time frame · 12 weeks

    Registry description

    \> 80% of its original diameter

  4. Symptomatic change and health-related quality of life

    Time frame · 4, 12 weeks and 24 weeks

    Registry description

    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

    Registry description

    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

    Registry description

    Long term proportional (%) and absolute change in cyst diameter measured by ultrasound 24 weeks after aspiration sclerotherapy.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2015

Aspiration sclerotherapy combined with pasireotide to improve reduction of large symptomatic hepatic cysts (SCLEROCYST): study protocol for a randomized controlled trial.

Wijnands et al. 2015Trialscited by 8

PMID 25873132PMC4355152DOI 10.1186/s13063-015-0607-3PUB-25873132

CC BY
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Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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