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

Not Applicable

Withdrawn

• Conditions: Vascular Surgical Procedures
• Interventions: Procedure: Ultrasound-guided subclavian vein puncture; Procedure: Cephalic vein dissection

• Registration Number: NCT01584193
• Lead Sponsor: University of Lausanne Hospitals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-21
• Study First Submitted QC: 2012-04-21
• Study First Posted: 2012-04-24
• Study Start: 2013-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US-guided subclavian vein puncture	Ultrasound-guided subclavian vein puncture	-
Cephalic vein dissection	Cephalic vein dissection	-

Primary Outcome Measures

Name	Time	Method
surgical procedure time	during surgical procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Lausanne, Department of Visceral Surgery; 🇨🇭 Lausanne, Vaud, Switzerland