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WithdrawnNCT01584193Updated Oct 23, 2018

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

An interventional study of Ultrasound-guided subclavian vein puncture and Cephalic vein dissection in Vascular Surgical Procedures, sponsored by University of Lausanne Hospitals. Withdrawn at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-23.

Sponsored by University of Lausanne Hospitals · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Logistical reasons (institutional reorganization of ambulatory surgery)
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Vascular Surgical Procedures

Keywords

  • central venous access port
  • ultrasound-guided venous puncture
  • suclavian vein
  • cephalic vein
03

In context

Lead sponsor

University of Lausanne Hospitals is the lead sponsor of 118 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    US-guided subclavian vein puncture

    Procedure: Ultrasound-guided subclavian vein puncture

  • Active comparator
    Cephalic vein dissection

    Procedure: Cephalic vein dissection

Interventions

  • ProcedureUltrasound-guided subclavian vein puncture

    Central venous access port implementation through ultrasound-guided subclavian vein puncture and Seldinger technique

    Also known as: US-guided, Seldinger technique

  • ProcedureCephalic vein dissection

    Central venous access port implementation through cephalic vein dissection and cutdown

    Also known as: Venous cutdown

06

What researchers measure

Primary outcomes

  1. surgical procedure time

    Time frame: during surgical procedure

Secondary outcomes

  1. primary implementation success rate

    Time frame: during surgical procedure

  2. overall implementation success rate

    Time frame: during surgical procedure

  3. technique conversion rate and causes

    Time frame: during surgical procedure

  4. pain during surgical procedure

    Time frame: during surgical procedure

  5. pain at 5 days

    Time frame: 5 days post-procedure

  6. Pain at 30 days

    Time frame: 30 days post-procedure

  7. Complications rate during surgical procedure

    catheter malposition, hemorrhage, hemotoma, hemothorax, pneumothorax

    Time frame: during surgical procedure

  8. Complications rate at 5 days

    hematoma, infection, symptomatic venous thrombosis, pneumothorax

    Time frame: 5 days post-procedure

  9. Complications rate at 30 days

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

    Time frame: 30 days post-procedure

07

Study locations

1 site
  • University Hospital Lausanne, Department of Visceral Surgery
    Lausanne, Vaud 1011, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01584193
Lead sponsor
University of Lausanne Hospitals
Responsible party
Nicolas DEMARTINES (Professor, University of Lausanne Hospitals) — Principal investigator
First posted
Apr 24, 2012
Start date
Jun 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Oct 23, 2018

Study contacts

Nicolas Demartines
study chair · University Hospital Lausanne, Department of Visceral Surgery

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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