Current partner codePEPTIDESDE
NCT02048319·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

34

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Pasireotide LAR 60 mg

Pasireotide long acting release, intramuscular injection

PROCEDURE

Aspiration sclerotherapy

Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation

DRUG

Placebo

Saline solution, injected as placebo

Timeline

From registration to results.

  1. First posted

    Jan 29, 2014

  2. Study start

    Dec 2013

  3. Primary completion

    Nov 2015

  4. Study completion

    Apr 2016

  5. Results posted

    Not reported

  6. Registry updated

    May 4, 2016

Outcomes

What the study measures.

Primary outcomes

Proportional diameter change

Time frame · 4 weeks

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

Secondary outcomes

Absolute reduction (cm) hepatic cyst

Time frame · 4 weeks

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

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

Proportion cyst recurrence

Time frame · 12 weeks

\> 80% of its original diameter

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

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

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

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Netherlands. Showing up to 24 locations stored in the fast local snapshot.

Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology

Nijmegen, Netherlands

Related trials

More studies on Pasireotide.

Related PeptideStat pages

Put the record in context.

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