Clinical trial NCT00272623: Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports
Official title: A Prospective, Randomized Trial Comparing Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2006-01-06
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implantation success rate
Secondary outcomes:
measure: Amount of puncture attempts needed (new perforation of the skin)
measure: Intraoperative change of surgical technique
measure: Operation time
measure: Intra-/perioperative complications (arterial puncture, major arrhythmia, pneumothorax, haemorrhage/haematoma)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Dept. of Visceral and Transplantation Surgery
state: ZH
Study officials:
affiliation: Dept. of Visceral and Transplantation Surgery, University Hospital Zurich
name: Markus Weber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nocito A, Wildi S, Rufibach K, Clavien PA, Weber M. Randomized clinical trial comparing venous cutdown with the Seldinger technique for placement of implantable venous access ports. Br J Surg. 2009 Oct;96(10):1129-34. doi: 10.1002/bjs.6730.