- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07197320
- Original Trial
Comparison of Outcomes of Right Internal Jugular Port Implantation in Patients With Right Versus Left Breast Cancer Undergoing Chemotherapy
Comparison of Outcomes of Right Internal Jugular Port Implantation in Patients With Right Versus Left Breast Cancer Undergoing Chemotherapy in Gorgan Medical Centers (2017-2024)
Study Overview
Status
Conditions
Detailed Description
Breast cancer is the most common malignancy among women worldwide. Chemotherapy remains a cornerstone of treatment, whether in neoadjuvant or adjuvant settings. Despite advancements in drug formulations, repeated intravenous injections frequently result in phlebitis and loss of venous access. As a result, many patients and physicians prefer the use of totally implantable venous access devices (ports). These devices consist of a catheter and a chamber, allowing direct administration of chemotherapy into a central vein, reducing endothelial damage.
However, ports carry risks including infection, venous thrombosis, skin necrosis, and mechanical failure. In breast cancer patients who undergo mastectomy or radiotherapy, the optimal side for port implantation is controversial. Some surgeons avoid the ipsilateral side due to concerns about complications, while others report no additional risk when proper technique is used.
This retrospective cohort study evaluates the patency and safety of ports implanted through the right internal jugular vein in patients with right- and left-sided breast cancer treated in Gorgan medical centers between 2017 and 2024. Patient records will be reviewed to collect demographic information, tumor laterality, type of breast surgery (mastectomy vs. breast-conserving surgery), use of radiotherapy, type of port, and follow-up outcomes. Complications including infection, thrombosis, and skin necrosis will be recorded. The primary endpoint is one-year port patency; secondary endpoints include complication rates and associations with clinical variables such as age, stage, smoking status, and prior radiotherapy.
This study aims to clarify whether the side of breast cancer affects the outcomes of right internal jugular port implantation, and to provide evidence to guide decision-making regarding optimal port placement in breast cancer patients requiring chemotherapy.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Pezhman Kharazm
- Phone Number: +989111751861
- Email: pezhmankh@goums.ac.ir
Study Locations
-
-
Outside of the US
-
Gorgan, Outside of the US, Iran, 4917956808
- 5Th Azar Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female patients with breast cancer (right or left side)
- Underwent chemotherapy port implantation via right internal jugular vein between 2017-2024 in Gorgan medical centers
Exclusion Criteria:
- Prior neck surgery or radiotherapy involving right jugular area
- Incomplete medical records
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Cohort 1
Patients with right-sided breast cancer who received a right internal jugular port
|
|
Cohort 2
Patients with left-sided breast cancer who received a right internal jugular port
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
. One-year port patency
Time Frame: 12 months after port implantation
|
Defined as functional port access without removal due to complications
|
12 months after port implantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infection
Time Frame: 12 months
|
Incidence of port-related infection
|
12 months
|
|
Thrombosis
Time Frame: 12 months
|
Incidence of port-related thrombosis
|
12 months
|
|
skin necrosis
Time Frame: 12 months
|
incidence of skin necrosis
|
12 months
|
|
cancer side association
Time Frame: 12 months
|
Association between port side relative to cancer side and complication rates
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 115103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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