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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01584193
Enrollment
0
Registered
2012-04-24
Start date
2013-06-30
Completion date
2014-12-31
Last updated
2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Surgical Procedures

Keywords

central venous access port, ultrasound-guided venous puncture, suclavian vein, cephalic vein

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.

Interventions

PROCEDUREUltrasound-guided subclavian vein puncture

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

PROCEDURECephalic vein dissection

Central venous access port implementation through cephalic vein dissection and cutdown

Sponsors

University of Lausanne Hospitals
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
surgical procedure timeduring surgical procedure

Secondary

MeasureTime frameDescription
overall implementation success rateduring surgical procedure
technique conversion rate and causesduring surgical procedure
pain during surgical procedureduring surgical procedure
pain at 5 days5 days post-procedure
primary implementation success rateduring surgical procedure
Complications rate during surgical procedureduring surgical procedurecatheter malposition, hemorrhage, hemotoma, hemothorax, pneumothorax
Complications rate at 5 days5 days post-procedurehematoma, infection, symptomatic venous thrombosis, pneumothorax
Complications rate at 30 days30 days post-procedureinfection, symptomatic venous thrombosis, pneumothorax, venous access port dysfunction
Pain at 30 days30 days post-procedure

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026