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

October 22, 2018 updated by: Nicolas DEMARTINES, University of Lausanne Hospitals

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • University Hospital Lausanne, Department of Visceral Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Venous cutdown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
surgical procedure time
Time Frame: during surgical procedure
during surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary implementation success rate
Time Frame: during surgical procedure
during surgical procedure
overall implementation success rate
Time Frame: during surgical procedure
during surgical procedure
technique conversion rate and causes
Time Frame: during surgical procedure
during surgical procedure
pain during surgical procedure
Time Frame: during surgical procedure
during surgical procedure
pain at 5 days
Time Frame: 5 days post-procedure
5 days post-procedure
Pain at 30 days
Time Frame: 30 days post-procedure
30 days post-procedure
Complications rate during surgical procedure
Time Frame: during surgical procedure
catheter malposition, hemorrhage, hemotoma, hemothorax, pneumothorax
during surgical procedure
Complications rate at 5 days
Time Frame: 5 days post-procedure
hematoma, infection, symptomatic venous thrombosis, pneumothorax
5 days post-procedure
Complications rate at 30 days
Time Frame: 30 days post-procedure
infection, symptomatic venous thrombosis, pneumothorax, venous access port dysfunction
30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

  • Study Chair: Nicolas Demartines, University Hospital Lausanne, Department of Visceral Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 21, 2012

First Submitted That Met QC Criteria

April 21, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHV 46/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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