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

NCT02048319 | Completed Phase 3 DMC

• 2 other identifiers: JDTW451152013-003168-29
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Liver cyst; Hepatic cyst; Symptomatic; Aspiration sclerotherapy

Outcome Measures

Primary Outcomes (1)

• Proportional diameter change

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

  4 weeks

Secondary Outcomes (6)

• Absolute reduction (cm) hepatic cyst

  4 weeks

• Proportional (%) and absolute cyst reduction (cm) after 12 weeks

  12 weeks

• Proportion cyst recurrence

  12 weeks

• Symptomatic change and health-related quality of life

  4, 12 weeks and 24 weeks

• Safety

  At week 2, week 4, week 6, week 14 and week 26 after first Pasireotide injection

Study Arms (2)

Experimental: Pasireotide LAR 60 mg

EXPERIMENTAL

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; Procedure: Aspiration sclerotherapy

Placebo

PLACEBO COMPARATOR

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

Procedure: Aspiration sclerotherapy; Drug: Placebo

Interventions

Pasireotide LAR 60 mg DRUG

Pasireotide long acting release, intramuscular injection

Also known as: Pasireotide long acting release, intramuscular injection

Experimental: Pasireotide LAR 60 mg

Aspiration sclerotherapy PROCEDURE

Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation

Also known as: Drainage with subsequent ethanol instillation

Experimental: Pasireotide LAR 60 mg; Placebo

Placebo DRUG

Saline solution, injected as placebo

Also known as: Saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study
• Signs of cyst bleeding on ultrasound
• Cyst \< 5 cm
• Coagulopathy (INR \> 2 or platelets \< 80 x 10\^9)
• Severe co-morbidity contraindicating anesthesia (i.e. ASA 4 classification)
• Patients with a known hypersensitivity to SST analogues or any component of the pasireotide LAR or SQ formulations
• Pregnant or nursing women
• Symptomatic cholecystolithiasis
• Known (congenital) long QT syndrome or QTcF at screening 470 msec
• Family history of long QT syndrome or idiopathic sudden death
• 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)
• Risk factors for torsades de pointes: hypokalemia, hypomagnesemia, hypocalcaemia, cardiac failure, clinically significant/symptomatic bradycardia, or high grade AV block
• 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
• Taking anti-arrhythmic medicinal products or other substances that are known to lead to QT prolongation
• Uncontrolled diabetes as defined by HbA1C \> 64 mmol/ml despite adequate therapy

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 25873132 DERIVED

MeSH Terms

Interventions

Injections, Intramuscular; Drainage; Saline Solution

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Surgical Procedures, Operative; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 29, 2014
• Study Start: December 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: April 1, 2016
• Last Updated: May 4, 2016

Record last verified: 2016-05

Locations

NL (1)