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

Further study details as provided by University of Zurich:

Primary Outcomes: Implantation success rate
Secondary Outcomes: 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)
Expected Total Enrollment:  152

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00272623

Antonio Nocito, MD      +41 44 255  Ext. 37 18    antonio.nocito@usz.ch
Stefan Wildi, MD      +41 44 255  Ext. 4223    stefan.wildi@usz.ch

Switzerland, ZH
      Dept. of Visceral and Transplantation Surgery, Zurich,  ZH,  8091,  Switzerland

Study chairs or principal investigators

Markus Weber, MD,  Principal Investigator,  Dept. of Visceral and Transplantation Surgery, University Hospital Zurich   

Study ID Numbers:  StV 33-2005
Last Updated:  January 5, 2006
Record first received:  January 3, 2006
ClinicalTrials.gov Identifier:  NCT00272623
Health Authority: Switzerland: Swissmedic
ClinicalTrials.gov processed this record on 2006-01-10