Cancer, Catheter Complications
Conditions
Keywords
implantable port
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.
Interventions
PROCEDURERight internal jugular access.
Implantation using percutaneous puncture.
PROCEDURELeft internal jugular access.
Implantation using percutaneous puncture.
PROCEDURERight axillary vein access.
Implantation using percutaneous puncture.
PROCEDURELeft axillary vein access.
Implantation using percutaneous puncture.
Sponsors
AC Camargo Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed