Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Randomized Trial Comparing Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports

Conditions
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Catheters, Indwelling

Intervention / Treatment
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* Procedure: Seldinger technique or venous cut-down for port placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Seldinger technique or venous cut-down for port placement|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation success rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of puncture attempts needed (new perforation of the skin) |  |  | 
| Intraoperative change of surgical technique |  |  | 
| Operation time |  |  | 
| Intra-/perioperative complications (arterial puncture, major arrhythmia, pneumothorax, haemorrhage/haematoma) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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