Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports

NCT03512899 | Completed DMC

• 1 other identifier: 63850017.5.0000.5432
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Complications; Cancer

Keywords

implantable port

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Late complications

  30 to 180 days

Study Arms (2)

Internal jugular vein access

ACTIVE COMPARATOR

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

Procedure: Right internal jugular access.; Procedure: Left internal jugular access.

Axillary vein access

ACTIVE COMPARATOR

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

Procedure: Right axillary vein access.; Procedure: Left axillary vein access.

Interventions

Right internal jugular access. PROCEDURE

Implantation using percutaneous puncture.

Internal jugular vein access

Left internal jugular access. PROCEDURE

Implantation using percutaneous puncture.

Internal jugular vein access

Right axillary vein access. PROCEDURE

Implantation using percutaneous puncture.

Axillary vein access

Left axillary vein access. PROCEDURE

Implantation using percutaneous puncture.

Axillary vein access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Catheter due to chemotherapy.
• Cancer patients.
• ECOG (performance status) from 0 to 2.
• Signed informed consent form.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

AC Camargo Cancer Center

São Paulo, 01509-010, Brazil

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Bruno S Pignataro

  Vascular and Endovascular Surgery Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: May 1, 2018
• Study Start: April 1, 2017
• Primary Completion: November 1, 2022
• Study Completion: November 10, 2022
• Last Updated: July 25, 2023

Record last verified: 2021-01

Locations

BR (1)