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| Sponsored by: |
University of Zurich |
|---|---|
| Information provided by: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT00272623 |
Purpose
Since the first placement of a totally implantable venous access port (TIVAP) by Niederhuber et al in 1982 its application to provide long-term central venous access has dramatically increased. These systems have dramatically simplified the administration of chemotherapy and parenteral nutrition as well as the repetitive collection of blood samples.
Initial retrospective studies have focused on the complications associated with different implantation techniques. Subsequently, major attention has been payed to the comparison of distinct types of TIVAPs. To date a variety of approved port systems are available. These devices can be either implanted using the Seldinger technique or by venous cut-down of the cephalic vein Despite the global use of these established implantation procedures prospective, randomized trials directly comparing these two approaches are still lacking. So, the choice, which technique to use is left to the surgeon’s preference.
The aim of this study is to directly compare the Seldinger technique versus cephalic vein cut down for placement of TIVAPs in respect of implantation success rate, operation time and perioperative morbidity.
| Condition | Intervention |
|---|---|
|
Catheters, Indwelling |
Procedure: Seldinger technique or venous cut-down for port placement |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Prospective, Randomized Trial Comparing Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports |
| Estimated Enrollment: | 152 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | February 2009 |
Since the first placement of a totally implantable venous access port (TIVAP) by Niederhuber et al in 1982 its application to provide long-term central venous access has dramatically increased. These systems have dramatically simplified the administration of chemotherapy and parenteral nutrition as well as the repetitive collection of blood samples.
Initial retrospective studies have focused on the complications associated with different implantation techniques. Subsequently, major attention has been payed to the comparison of distinct types of TIVAPs. To date a variety of approved port systems are available. These devices can be either implanted using the Seldinger technique or by venous cut-down of the cephalic vein Despite the global use of these established implantation procedures prospective, randomized trials directly comparing these two approaches are still lacking. So, the choice, which technique to use is left to the surgeon’s preference.
The aim of this study is to directly compare the Seldinger technique versus cephalic vein cut down for placement of TIVAPs in respect of implantation success rate, operation time and perioperative morbidity.
After an informed consent has been obtained, patients will be randomized as follows: By means of sealed envelopes a total of 152 patients will be allocated either to TIVAP placement using Seldinger technique or by venous cut down (n= 76 in each group).
Operations will be performed in local or general anaesthesia either on an outpatient basis or via 24h-admission. Changes of technique due to catheter implantation failure, operation time and intraoperative complications will be assessed during the procedure. Postoperative examination will be standardized in both groups, i.e. chest radiography (to confirm catheter placement and to exclude pneumothorax) as well as final clinical examination at discharge or before patient transfer.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Antonio Nocito, MD | +41 44 255 ext 37 18 | antonio.nocito@usz.ch |
| Contact: Stefan Wildi, MD | +41 44 255 ext 4223 | stefan.wildi@usz.ch |
| Switzerland, ZH | |
| Dept. of Visceral and Transplantation Surgery | Recruiting |
| Zurich, ZH, Switzerland, 8091 | |
| Contact: Markus Weber, MD +41 44 255 ext 3300 markus.weber@usz.ch | |
| Contact: Antonio Nocito, MD +41 44 255 ext 3718 antonio.nocito@usz.ch | |
| Principal Investigator: Markus Weber, MD | |
| Sub-Investigator: Stefan Wildi, MD | |
| Sub-Investigator: Antonio Nocito, MD | |
| Principal Investigator: | Markus Weber, MD | Dept. of Visceral and Transplantation Surgery, University Hospital Zurich |
More Information
| Study ID Numbers: | StV 33-2005 |
| Study First Received: | January 3, 2006 |
| Last Updated: | April 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00272623 |
| Health Authority: | Switzerland: Swissmedic |
|
Catheter, Indwelling Indwelling Catheter Indwelling Catheters Implantable Catheters Catheter, Implantable Catheters, Implantable Implantable Catheter In-Dwelling Catheters Catheter, In-Dwelling Catheters, In-Dwelling In Dwelling Catheters |
In-Dwelling Catheter Venous Reservoirs Reservoir, Venous Reservoirs, Venous Venous Reservoir Vascular Access Ports Access Port, Vascular Access Ports, Vascular Port, Vascular Access Ports, Vascular Access Vascular Access Port |
