Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports

Study Overview
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Brief Summary
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Comparison between internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 12 months.

Detailed Description
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Prospective and randomized trial comparing internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm in a single center study at AC Camargo Cancer Center. Every surgery is assisted by ultrasound and radioscopic and the catheter is districath®, 8.5 French. Clinical assessment will be at 10 days and every 3 months after surgery. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 12 months.

Official Title
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Internal Jugular Vein Versus Axillary Vein With Single-incision for Implantable Ports: a Prospective and Randomized Study.

Conditions
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Catheter Complications, Cancer

Intervention / Treatment
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* Procedure: Right internal jugular access.
* Procedure: Left internal jugular access.
* Procedure: Right axillary vein access.
* Procedure: Left axillary vein access.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Catheter due to chemotherapy. Cancer patients. ECOG (performance status) from 0 to 2. Signed informed consent form. Exclusion Criteria: Non compliance. Anticoagulant therapy. Coagulopathy (platelet count below 50,000 and/or protrombin time above 18s). Death within 30 days after the procedure. Another catheter in superior vena cava. Previous long term catheter in superior vena cava. Obesity (IBM>40 Kg/m2).

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
Interventional Model Description: Comparison between internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 6 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Internal jugular vein access<br>Internal jugular vein access preferably right, assisted by ultrasound and radioscopy. Catheter: districath®, 8.5 French. | Procedure: Right internal jugular access.<br>* Implantation using percutaneous puncture.<br>Procedure: Left internal jugular access.<br>* Implantation using percutaneous puncture.<br>|
| Active Comparator: Axillary vein access<br>Axillary vein access with single incision, assisted by ultrasound and radioscopy. Catheter: districath®, 8.5 French. | Procedure: Right axillary vein access.<br>* Implantation using percutaneous puncture.<br>Procedure: Left axillary vein access.<br>* Implantation using percutaneous puncture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early complications. | Early complications within 30 days during clinical assessment. These outcomes are divided in intra-operative complications, such as pneumothorax, hemothorax, vascular injury, cardiac arrhythmia, hematoma; and post-operative until 30 days complications such as wound infections, catheter related bacteremia, catheter disfunction, catheter related deep venous thrombosis, reservoir extrusion and skin erosion. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late complications | Post-operative between 30 days and 6 months complications such as wound infections, catheter related bacteremia, catheter disfunction, catheter related deep venous thrombosis, reservoir extrusion and skin erosion. | 30 to 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implantable port