Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports

AC Camargo Cancer Center

Status: Completed

Conditions: Catheter Complications; Cancer

Treatments: Procedure: Right internal jugular access.; Procedure: Left internal jugular access.; Procedure: Right axillary vein access.; Procedure: Left axillary vein access.

Study type: Interventional

Funder types: Other

Identifiers

NCT03512899

63850017.5.0000.5432

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Internal jugular vein access

Active Comparator group

Description:

Internal jugular vein access preferably right, assisted by ultrasound and radioscopy. Catheter: districath®, 8.5 French.

Treatment:

Procedure: Right internal jugular access.

Procedure: Left internal jugular access.

Axillary vein access

Active Comparator group

Description:

Axillary vein access with single incision, assisted by ultrasound and radioscopy. Catheter: districath®, 8.5 French.

Treatment:

Procedure: Left axillary vein access.

Procedure: Right axillary vein access.