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

Intervention / Treatment

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 Locations

  • Brazil
      • São Paulo, Brazil, 01509-010
        • AC Camargo Cancer 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

14 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.
Procedure: Right internal jugular access.
Implantation using percutaneous puncture.
Procedure: Left internal jugular access.
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.
Procedure: Right axillary vein access.
Implantation using percutaneous puncture.
Procedure: Left axillary vein access.
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

AC Camargo Cancer Center

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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