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

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00272623
First received: January 3, 2006
Last updated: June 2, 2009
Last verified: June 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial Comparing Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Implantation success rate

Secondary Outcome Measures:
  • 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)

Enrollment: 152
Study Start Date: January 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272623

Locations
Switzerland
Dept. of Visceral and Transplantation Surgery
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Markus Weber, MD Dept. of Visceral and Transplantation Surgery, University Hospital Zurich
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00272623     History of Changes
Other Study ID Numbers: StV 33-2005
Study First Received: January 3, 2006
Last Updated: June 2, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
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

ClinicalTrials.gov processed this record on September 16, 2014