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

NCT ID: NCT02048319

Last Updated: 2016-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-04-30

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.

Conditions

Symptomatic Dominant Liver Cyst

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pasireotide LAR 60 mg

Intervention Type: DRUG

Pasireotide long acting release, intramuscular injection

Aspiration sclerotherapy

Intervention Type: PROCEDURE

Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation

Placebo

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

Group Type: PLACEBO_COMPARATOR

Aspiration sclerotherapy

Intervention Type: PROCEDURE

Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation

Placebo

Intervention Type: DRUG

Saline solution, injected as placebo

Interventions

Pasireotide LAR 60 mg

Pasireotide long acting release, intramuscular injection

Intervention Type: DRUG

Aspiration sclerotherapy

Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation

Intervention Type: PROCEDURE

Placebo

Saline solution, injected as placebo

Intervention Type: DRUG

Other Intervention Names

Pasireotide long acting release, intramuscular injection; Drainage with subsequent ethanol instillation; Saline solution

Eligibility 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

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)

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

• 9.1 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology

Nijmegen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 25873132 (View on PubMed)

Other Identifiers

2013-003168-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

JDTW45115

Identifier Type: -

Identifier Source: org_study_id