Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
6 participants
INTERVENTIONAL
2010-09-30
Brief Summary
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Detailed Description
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The liver PILP intervention will be considered feasible if the procedure is demonstrated to be safe and the liver PILP kit performs according to specifications.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Liver-PILP kit
Liver-PILP kit
Liver-PILP kit
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.
Interventions
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Liver-PILP kit
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.
Eligibility Criteria
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Inclusion Criteria
2. Unresectable metastatic disease predominant in the liver
Exclusion Criteria
2. Abnormal vascular anatomy
3. Severe atherosclerosis
4. Dissection and/or thrombotic occlusion and/or aneurysm of the aorta, iliac or hepatic arteries
5. Short suprahepatic vena cava segment (\< 1.5 cm)
6. One or both jugular veins are occluded
7. Other severe, concomitant diseases regarding the subject status
18 Years
ALL
No
Sponsors
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Celerion
INDUSTRY
Cromsource
INDUSTRY
Medical Device Works NV SA
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Van Cutsem, Prof MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Leuven, Catholic University
Karen Geboes, Prof MD Phd
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Luc Defreyne, Prof MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Marc Van den Eynde, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Louvain Saint-Luc
Locations
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University Hospital Louvain Saint-Luc
Brussels, , Belgium
University Hospital Ghent
Ghent, , Belgium
University Hospitals Leuven, Catholic University
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Marc Van den Eynce, MD
Role: primary
Luc Defreyne, Prof MD PhD
Role: primary
Karen Geboes, Prof MD PhD
Role: backup
Eric Van Cutsem, Prof MD PhD
Role: primary
References
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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.
Other Identifiers
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CIP 000369
Identifier Type: -
Identifier Source: org_study_id