- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00272623
Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports
A Prospective, Randomized Trial Comparing Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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ZH
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Zurich, ZH, Switzerland, 8091
- Dept. of Visceral and Transplantation Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Oncological patients with an indication for a long-term parenteral treatment
- Age > 18 years
- Elective operations only
Exclusion Criteria:
- Patients with limited German proficiency (informed consent not possible)
- Anticoagulation (INR >2.5), coagulopathy, Tc<60'000/mI
- Bilateral intervention/irradiation on shoulder, clavicle or breast
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Implantation success rate
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Secondary Outcome Measures
Outcome Measure |
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Operation time
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Amount of puncture attempts needed (new perforation of the skin)
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Intraoperative change of surgical technique
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Intra-/perioperative complications (arterial puncture, major arrhythmia, pneumothorax, haemorrhage/haematoma)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Indwelling Catheter
- Catheter, Indwelling
- 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
Other Study ID Numbers
- StV 33-2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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