- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03512899
Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports
July 24, 2023 updated by: AC Camargo Cancer Center
Internal Jugular Vein Versus Axillary Vein With Single-incision for Implantable Ports: a Prospective and Randomized Study.
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bruno S Pignataro, MD
- Phone Number: 551121895000
- Email: brunosoriano86@yahoo.com.br
Study Contact Backup
- Name: Sandra C Serrano
- Phone Number: 5020 551121895000
- Email: hcancer@accamargo.org.br
Study Locations
-
-
-
São Paulo, Brazil, 01509-010
- AC Camargo Câncer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Internal jugular vein access
Internal jugular vein access preferably right, assisted by ultrasound and radioscopy.
Catheter: districath®, 8.5 French.
|
Implantation using percutaneous puncture.
Implantation using percutaneous puncture.
|
Active Comparator: Axillary vein access
Axillary vein access with single incision, assisted by ultrasound and radioscopy.
Catheter: districath®, 8.5 French.
|
Implantation using percutaneous puncture.
Implantation using percutaneous puncture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 to 180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruno S Pignataro, Vascular and Endovascular Surgery Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Actual)
November 1, 2022
Study Completion (Actual)
November 10, 2022
Study Registration Dates
First Submitted
February 6, 2018
First Submitted That Met QC Criteria
April 27, 2018
First Posted (Actual)
May 1, 2018
Study Record Updates
Last Update Posted (Actual)
July 25, 2023
Last Update Submitted That Met QC Criteria
July 24, 2023
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 63850017.5.0000.5432
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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