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NCT Number: NCT03512899

Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports

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.

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Key information

Conditions

Catheter Complications Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AC Camargo Cancer Center

São Paulo, 01509-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Right internal jugular access.

Procedure

Implantation using percutaneous puncture.

Left internal jugular access.

Procedure

Implantation using percutaneous puncture.

Right axillary vein access.

Procedure

Implantation using percutaneous puncture.

Left axillary vein access.

Procedure

Implantation using percutaneous puncture.

Primary outcomes

  1. Early complications.

    Time frame: 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 outcomes

  1. Late complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AC Camargo Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 1, 2018
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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