Catheter ComplicationsNCT03512899
Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports
A study testing Right internal jugular access., Left internal jugular access. and Right axillary vein access. in people with Catheter Complications and Cancer, run by AC Camargo Cancer Center at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Complications, Cancer
- What is being tested?
- Right internal jugular access., Left internal jugular access. and Right axillary vein access.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2017to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Catheter due to chemotherapy.
- Cancer patients.
- ECOG (performance status) from 0 to 2.
- Signed informed consent form.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Catheter Complications, Cancer
- Being tested
- Right internal jugular access., Left internal jugular access., Right axillary vein access., Left axillary vein access.
- Keywords
- implantable port
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right internal jugular access.Procedure or surgery
Implantation using percutaneous puncture.
Left internal jugular access.Procedure or surgery
Implantation using percutaneous puncture.
Right axillary vein access.Procedure or surgery
Implantation using percutaneous puncture.
Left axillary vein access.Procedure or surgery
Implantation using percutaneous puncture.
| Study group | Role | What they receive |
|---|---|---|
| Internal jugular vein access | Active comparator | Internal jugular vein access preferably right, assisted by ultrasound and radioscopy. Catheter: districath®, 8.5 French. Receives: 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. Receives: Procedure: Right axillary vein access.; Procedure: Left axillary vein access. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
Late complications
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.
Measured: 30 to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Apr 2017
- Primary completion1 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno S Pignataro, Principal investigator, Vascular and Endovascular Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512899
- Sponsor's protocol ID
- 63850017.5.0000.5432
- Status last verified
- Jan 2021
- First submitted
- 6 Feb 2018
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Jugular Vein Versus Axillary Vein With Single-incision for Implantable Ports: a Prospective and Randomized Study.
- ClinicalTrials.gov ID
- NCT03512899
- Acronym / sponsor ID
- 63850017.5.0000.5432
- Conditions
- Catheter Complications, Cancer
- Keywords
- implantable port
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Internal jugular vein access | Active comparator | Procedure: Right internal jugular access., Procedure: Left internal jugular access.Internal jugular vein access preferably right, assisted by ultrasound and radioscopy. Catheter: districath®, 8.5 French. |
| Axillary vein access | Active comparator | Procedure: Right axillary vein access., Procedure: Left axillary vein access.Axillary vein access with single incision, assisted by ultrasound and radioscopy. Catheter: districath®, 8.5 French. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Catheter due to chemotherapy.
- Cancer patients.
- ECOG (performance status) from 0 to 2.
- Signed informed consent form.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right internal jugular access.Implantation using percutaneous puncture. | Procedure or surgery | Internal jugular vein access |
| Left internal jugular access.Implantation using percutaneous puncture. | Procedure or surgery | Internal jugular vein access |
| Right axillary vein access.Implantation using percutaneous puncture. | Procedure or surgery | Axillary vein access |
| Left axillary vein access.Implantation using percutaneous puncture. | Procedure or surgery | Axillary vein access |
Primary outcome
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.
1 secondary outcome
Late complications
Time frame: 30 to 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
Related trials for Catheter Complications
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
Ureteropelvic Junction Obstruction, Hypospadias
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer
Bladder Cancer
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno S Pignataro principal investigator
Vascular and Endovascular Surgery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right internal jugular access., Left internal jugular access. and Right axillary vein access. in people with Catheter Complications and Cancer, run by AC Camargo Cancer Center at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early complications. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.