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Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports
This study has been completed.
Study NCT00272623   Information provided by University of Zurich
First Received: January 3, 2006   Last Updated: June 2, 2009   History of Changes

January 3, 2006
June 2, 2009
January 2006
October 2008   (final data collection date for primary outcome measure)
Implantation success rate
Same as current
Complete list of historical versions of study NCT00272623 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
 
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.

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.

 
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Catheters, Indwelling
Procedure: Seldinger technique or venous cut-down for port placement
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
152
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00272623
 
StV 33-2005
University of Zurich
 
Principal Investigator: Markus Weber, MD Dept. of Visceral and Transplantation Surgery, University Hospital Zurich
University of Zurich
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP