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Sponsored by: |
University of Heidelberg |
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Information provided by: | University of Heidelberg |
ClinicalTrials.gov Identifier: | NCT00600444 |
The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.
Condition | Intervention |
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Cancer |
Procedure: Venae sectio Procedure: Punction of V. subclavia |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port |
Estimated Enrollment: | 100 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon
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Procedure: Venae sectio
surgical preparation of the cephalic vene to insert a totally implantable access port.
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B: Experimental
Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.
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Procedure: Punction of V. subclavia
radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Phillip Knebel, MD | 0049 6221 5639652 | phillip.knebel@med.uni-heidelberg.de |
Germany, Baden Würtemberg | |
University of Heidelberg | Recruiting |
Heidelberg, Baden Würtemberg, Germany, 69120 | |
Contact: Phillip Knebel, MD 0049 6221 5639652 phillip.knebel@med.uni-heidelberg.de |
Principal Investigator: | Markus W Büchler, Prof. Dr. | University of Heidelberg, Department of General, Visceral and Transplantation Surgery |
Responsible Party: | University of Heidelberg, Department of General, Visceral and Transplantation Surgery ( Prof. Dr. med. M. W. Büchler, Chairman Department of Surgery ) |
Study ID Numbers: | KSC01/08 |
Study First Received: | January 14, 2008 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00600444 |
Health Authority: | Germany: Ethics Commission |
permanent venous access chemotherapy parenteral nutrition |
Patients with a benign and/or malignant diseases which demand a safe and permanent venous access, e.g. for chemotherapy and/or parenteral nutrition benign diseases malignant diseases |