Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Venous Access Port Implantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Lausanne Hospitals.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01584193
First received: April 21, 2012
Last updated: May 7, 2012
Last verified: May 2012

April 21, 2012
May 7, 2012
May 2012
February 2014   (final data collection date for primary outcome measure)
surgical procedure time [ Time Frame: during surgical procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01584193 on ClinicalTrials.gov Archive Site
  • primary implementation success rate [ Time Frame: during surgical procedure ] [ Designated as safety issue: No ]
  • overall implementation success rate [ Time Frame: during surgical procedure ] [ Designated as safety issue: No ]
  • technique conversion rate and causes [ Time Frame: during surgical procedure ] [ Designated as safety issue: No ]
  • pain during surgical procedure [ Time Frame: during surgical procedure ] [ Designated as safety issue: No ]
  • pain at 5 days [ Time Frame: 5 days post-procedure ] [ Designated as safety issue: No ]
  • Pain at 30 days [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: No ]
  • Complications rate during surgical procedure [ Time Frame: during surgical procedure ] [ Designated as safety issue: Yes ]
    catheter malposition, hemorrhage, hemotoma, hemothorax, pneumothorax
  • Complications rate at 5 days [ Time Frame: 5 days post-procedure ] [ Designated as safety issue: Yes ]
    hematoma, infection, symptomatic venous thrombosis, pneumothorax
  • Complications rate at 30 days [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: Yes ]
    infection, symptomatic venous thrombosis, pneumothorax, venous access port dysfunction
Same as current
Not Provided
Not Provided
 
Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Venous Access Port Implantation
Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Totally Implantable Venous Access Port Implementation: a Single-center Controlled Randomized Superiority Trial

The purpose of this study is to compare two different surgical techniques for implementation of totally implantable central venous access ports. Ultrasound-guided suclavian vein puncture is compared to cephalic vein dissection.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Vascular Surgical Procedures
  • Procedure: Ultrasound-guided subclavian vein puncture
    Central venous access port implementation through ultrasound-guided subclavian vein puncture and Seldinger technique
    Other Names:
    • US-guided
    • Seldinger technique
  • Procedure: Cephalic vein dissection
    Central venous access port implementation through cephalic vein dissection and cutdown
    Other Name: Venous cutdown
  • Experimental: US-guided subclavian vein puncture
    Intervention: Procedure: Ultrasound-guided subclavian vein puncture
  • Active Comparator: Cephalic vein dissection
    Intervention: Procedure: Cephalic vein dissection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
172
Not Provided
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18
  • Informed consent
  • Need for central venous access port implementation under local anesthesia

Exclusion Criteria:

  • Impaired blood clotting
  • Ongoing antiplatelet drugs therapy, except acetylsalicylic acid
  • Trauma or surgical past history on both shoulder girdles
  • Known central venous thrombosis (subclavian vein, upper vena cava)
  • Known pneumothorax
  • Septic state
  • Agranulocytosis
Both
18 Years and older
No
Contact: Marc Dufour +41795567489 Marc.Dufour@chuv.ch
Contact: Martin Hubner +41795561506 Martin.Hubner@chuv.ch
Switzerland
 
NCT01584193
CHV 46/11
No
Nicolas DEMARTINES, University of Lausanne Hospitals
University of Lausanne Hospitals
Not Provided
Study Chair: Nicolas Demartines University Hospital Lausanne, Department of Visceral Surgery
University of Lausanne Hospitals
May 2012

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