Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512899
• Other study ID #: 63850017.5.0000.5432
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: November 10, 2022

Study information

• Verified date: January 2021
• Source: AC Camargo Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 10, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer
• Catheter Complications

Intervention

Procedure:
• Right internal jugular access.
Implantation using percutaneous puncture.
• Left internal jugular access.
Implantation using percutaneous puncture.
• Right axillary vein access.
Implantation using percutaneous puncture.
• Left axillary vein access.
Implantation using percutaneous puncture.

Locations

Country	Name	City	State
Brazil	AC Camargo Cancer Center	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
AC Camargo Cancer Center

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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