NCT01250158

Brief Summary

The purpose of this study is to determine whether the PILP-kit can be safely used, within specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic drug for the treatment of patients with unresectable liver metastases.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

3.3 years

First QC Date

November 26, 2010

Last Update Submit

March 28, 2013

Conditions

Liver Metastases

Keywords

Liver Percutaneous Isolated Localized PerfusionPILPIsolated Hepatic PerfusionIHPLiver metastasesUnresectable liver metastases of different etiologies

Outcome Measures

Primary Outcomes (1)

  • To demonstrate the feasibility of the liver PILP intervention.

    The liver PILP intervention will be considered feasible if the intervention is demonstrated to be safe and the PILP kit performs according to specifications related to localization, flow rates and retrieval of devices.

    During intervention and up to 30 days post intervention

Study Arms (1)

Liver-PILP kit

EXPERIMENTAL

Liver-PILP kit

Device: Liver-PILP kit

Interventions

Liver-PILP kitDEVICE

Device: Liver-PILP kit The Liver-PILP kit (three devices) is composed of percutaneous, disposable (single-use), catheter-based devices for targeted, isolated, organ specific (liver), drug delivery and perfusion with high dose drugs. 1. The Portal Vein Device (PVD): balloon catheter to occlude the portal vein and allow aspiration through a central lumen for portal veno-venous bypass. 2. The Hepatic Artery Device (HAD): balloon catheter to occlude arterial flow to the liver. 3. The Vena Cava Device (VCD): catheter based device to isolate and access hepatic outflow to vena cava by creating a closed chamber in vena cava at ostia of the hepatic veins while maintaining central vena cava blood flow from lower extremities to right atrium through reduced central lumen.

Liver-PILP kit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with ECOG (Eastern Cooperative Oncology Group) stages 0 or 1
  • Unresectable metastatic disease predominant in the liver

You may not qualify if:

  • More than 60 % tumor involved liver tissue
  • Abnormal vascular anatomy
  • Severe atherosclerosis
  • Dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries
  • Short suprahepatic vena cava segment (\< 1.5 cm)
  • One or both jugular veins are occluded
  • Other severe, concomitant diseases regarding the subject status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Louvain Saint-Luc

Brussels, 1200, Belgium

RECRUITING

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

University Hospitals Leuven, Catholic University

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

  • Maleux G, Monbaliu D, Verslype C, Casteleyn C, Van De Velde M, Cornillie P, Hoogeveen Y, Van Cutsem E. Percutaneous isolated liver perfusion with occlusion balloons and a catheter-based stent-graft-like perfusion device: an experimental study in a porcine model. Eur Radiol. 2010 Oct;20(10):2372-80. doi: 10.1007/s00330-010-1816-5. Epub 2010 May 22.

    PMID: 20495978BACKGROUND

Study Officials

  • Eric Van Cutsem, Prof MD PhD

    University Hospitals Leuven, Catholic University

    PRINCIPAL INVESTIGATOR

  • Karen Geboes, Prof MD Phd

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

  • Luc Defreyne, Prof MD PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

  • Marc Van den Eynde, MD

    University Hospital Louvain Saint-Luc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Van Cutsem, Prof MD PhD

CONTACT

+32 16 344218Eric.VanCutsem@uz.kuleuven.ac.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2010

First Posted

November 30, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2014

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

BE(3)