ClinicalTrials.Veeva

Menu

Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports

A

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)

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.

Trial contacts and locations

1

Loading...

Central trial contact

Sandra C Serrano; Bruno S Pignataro, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems