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

Vascular Surgical Procedures Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01584193
• Other study ID #: CHV 46/11
• Status: Withdrawn
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2018
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Surgical Procedures

Intervention

Procedure:
• Ultrasound-guided subclavian vein puncture
Central venous access port implementation through ultrasound-guided subclavian vein puncture and Seldinger technique
• Cephalic vein dissection
Central venous access port implementation through cephalic vein dissection and cutdown

Locations

Country	Name	City	State
Switzerland	University Hospital Lausanne, Department of Visceral Surgery	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical procedure time		during surgical procedure
Secondary	primary implementation success rate		during surgical procedure
Secondary	overall implementation success rate		during surgical procedure
Secondary	technique conversion rate and causes		during surgical procedure
Secondary	pain during surgical procedure		during surgical procedure
Secondary	pain at 5 days		5 days post-procedure
Secondary	Pain at 30 days		30 days post-procedure
Secondary	Complications rate during surgical procedure	catheter malposition, hemorrhage, hemotoma, hemothorax, pneumothorax	during surgical procedure
Secondary	Complications rate at 5 days	hematoma, infection, symptomatic venous thrombosis, pneumothorax	5 days post-procedure
Secondary	Complications rate at 30 days	infection, symptomatic venous thrombosis, pneumothorax, venous access port dysfunction	30 days post-procedure