Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports

Not Applicable

Completed

• Conditions: Catheter Complications; Cancer

• Registration Number: NCT03512899
• Lead Sponsor: AC Camargo Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-05-01
• Status Verified: 2021-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-10
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Early complications.	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Late complications	30 to 180 days	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.

Trial Locations

Locations (1)

AC Camargo Cancer Center; 🇧🇷 São Paulo, Brazil