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

NCT00272623 | Completed

• 1 other identifier: StV 33-2005
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Implantation success rate

Secondary Outcomes (4)

• 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)

Interventions

Seldinger technique or venous cut-down for port placement PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Oncological patients with an indication for a long-term parenteral treatment
• Age \> 18 years
• Elective operations only

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Dept. of Visceral and Transplantation Surgery

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 19731229 DERIVED

Study Officials

• Markus Weber, MD

  Dept. of Visceral and Transplantation Surgery, University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 3, 2006
• First Posted: January 6, 2006
• Study Start: January 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 3, 2009

Record last verified: 2009-06

Locations

CH (1)