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Clinical Trials/NCT01584193
NCT01584193
Withdrawn
Not Applicable

Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Totally Implantable Venous Access Port Implementation: a Single-center Controlled Randomized Superiority Trial

University of Lausanne Hospitals1 site in 1 countryJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Surgical Procedures
Sponsor
University of Lausanne Hospitals
Locations
1
Primary Endpoint
surgical procedure time
Status
Withdrawn
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
December 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Lausanne Hospitals
Responsible Party
Principal Investigator
Principal Investigator

Nicolas DEMARTINES

Professor

University of Lausanne Hospitals

Eligibility 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

Outcomes

Primary Outcomes

surgical procedure time

Time Frame: during surgical procedure

Secondary Outcomes

  • technique conversion rate and causes(during surgical procedure)
  • primary implementation success rate(during surgical procedure)
  • Pain at 30 days(30 days post-procedure)
  • Complications rate at 30 days(30 days post-procedure)
  • pain during surgical procedure(during surgical procedure)
  • pain at 5 days(5 days post-procedure)
  • overall implementation success rate(during surgical procedure)
  • Complications rate during surgical procedure(during surgical procedure)
  • Complications rate at 5 days(5 days post-procedure)

Study Sites (1)

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