Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports

NCT ID: NCT03512899

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2022-11-10

Brief Summary

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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

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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

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Catheter Complications Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internal jugular vein access

Internal jugular vein access preferably right, assisted by ultrasound and radioscopy. Catheter: districath®, 8.5 French.

Group Type ACTIVE_COMPARATOR

Right internal jugular access.

Intervention Type PROCEDURE

Implantation using percutaneous puncture.

Left internal jugular access.

Intervention Type PROCEDURE

Implantation using percutaneous puncture.

Axillary vein access

Axillary vein access with single incision, assisted by ultrasound and radioscopy. Catheter: districath®, 8.5 French.

Group Type ACTIVE_COMPARATOR

Right axillary vein access.

Intervention Type PROCEDURE

Implantation using percutaneous puncture.

Left axillary vein access.

Intervention Type PROCEDURE

Implantation using percutaneous puncture.

Interventions

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Right internal jugular access.

Implantation using percutaneous puncture.

Intervention Type PROCEDURE

Left internal jugular access.

Implantation using percutaneous puncture.

Intervention Type PROCEDURE

Right axillary vein access.

Implantation using percutaneous puncture.

Intervention Type PROCEDURE

Left axillary vein access.

Implantation using percutaneous puncture.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AC Camargo Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruno S Pignataro

Role: PRINCIPAL_INVESTIGATOR

Vascular and Endovascular Surgery Department

Locations

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AC Camargo Cancer Center

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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63850017.5.0000.5432

Identifier Type: -

Identifier Source: org_study_id

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