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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vascular Surgical Procedures

Intervention / Treatment
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* Procedure: Ultrasound-guided subclavian vein puncture
* Procedure: Cephalic vein dissection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: US-guided subclavian vein puncture<br> | Procedure: Ultrasound-guided subclavian vein puncture<br>* Central venous access port implementation through ultrasound-guided subclavian vein puncture and Seldinger technique<br>* Other names: Seldinger technique;|
| Active Comparator: Cephalic vein dissection<br> | Procedure: Cephalic vein dissection<br>* Central venous access port implementation through cephalic vein dissection and cutdown<br>* Other names: Venous cutdown;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical procedure time |  | during surgical procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central venous access port, ultrasound-guided venous puncture, suclavian vein, cephalic vein