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

Sponsor
University of Lausanne Hospitals (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01584193
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
18
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound-guided subclavian vein puncture
  • Procedure: Cephalic vein dissection
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. surgical procedure time [during surgical procedure]

    Secondary Outcome Measures

    1. primary implementation success rate [during surgical procedure]

    2. overall implementation success rate [during surgical procedure]

    3. technique conversion rate and causes [during surgical procedure]

    4. pain during surgical procedure [during surgical procedure]

    5. pain at 5 days [5 days post-procedure]

    6. Pain at 30 days [30 days post-procedure]

    7. Complications rate during surgical procedure [during surgical procedure]

      catheter malposition, hemorrhage, hemotoma, hemothorax, pneumothorax

    8. Complications rate at 5 days [5 days post-procedure]

      hematoma, infection, symptomatic venous thrombosis, pneumothorax

    9. Complications rate at 30 days [30 days post-procedure]

      infection, symptomatic venous thrombosis, pneumothorax, venous access port dysfunction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University Hospital Lausanne, Department of Visceral Surgery Lausanne Vaud Switzerland 1011

    Sponsors and Collaborators

    • University of Lausanne Hospitals

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicolas DEMARTINES, Professor, University of Lausanne Hospitals
    ClinicalTrials.gov Identifier:
    NCT01584193
    Other Study ID Numbers:
    • CHV 46/11
    First Posted:
    Apr 24, 2012
    Last Update Posted:
    Oct 23, 2018
    Last Verified:
    Oct 1, 2018
    Keywords provided by Nicolas DEMARTINES, Professor, University of Lausanne Hospitals
    central venous access port
    ultrasound-guided venous puncture
    suclavian vein
    cephalic vein

    Study Results

    No Results Posted as of Oct 23, 2018