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

This study is not yet open for participant recruitment.
Verified May 2012 by University of Lausanne Hospitals
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
History of Changes
  Purpose

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.


Condition Intervention
Vascular Surgical Procedures
 Procedure: Ultrasound-guided subclavian vein puncture
Procedure: Cephalic vein dissection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Totally Implantable Venous Access Port Implementation: a Single-center Controlled Randomized Superiority Trial

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • surgical procedure time [ Time Frame: during surgical procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 172
Study Start Date: May 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: US-guided subclavian vein puncture 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
Active Comparator: Cephalic vein dissection Procedure: Cephalic vein dissection
Central venous access port implementation through cephalic vein dissection and cutdown
Other Name: Venous cutdown

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584193

Contacts
Contact: Marc Dufour +41795567489 Marc.Dufour@chuv.ch
Contact: Martin Hubner +41795561506 Martin.Hubner@chuv.ch

Locations
Switzerland
University Hospital Lausanne, Department of Visceral Surgery Not yet recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Marc Dufour     +41795567489     marc.dufour@gmail.com    
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Study Chair: Nicolas Demartines University Hospital Lausanne, Department of Visceral Surgery
  More Information

No publications provided

Responsible Party: Nicolas DEMARTINES, Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01584193     History of Changes
Other Study ID Numbers: CHV 46/11
Study First Received: April 21, 2012
Last Updated: May 7, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:
central venous access port
ultrasound-guided venous puncture
suclavian vein
cephalic vein

ClinicalTrials.gov processed this record on May 23, 2013