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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00272623
Enrollment
152
Registered
2006-01-06
Start date
2006-01-31
Completion date
2008-10-31
Last updated
2009-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheters, Indwelling

Keywords

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

Brief summary

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

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.

Interventions

PROCEDURESeldinger technique or venous cut-down for port placement

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Implantation success rate

Secondary

MeasureTime 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)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026