Port-A-CathNCT07197320
Comparison of Outcomes of Right Internal Jugular Port Implantation in Patients With Right Versus Left Breast Cancer Undergoing Chemotherapy
An observational study of Port-A-Cath, run by Golestan University of Medical sciences at 1 site in Iran.
Trial summary
Chemotherapy is an essential component of breast cancer treatment. Frequent intravenous injections may lead to phlebitis and limited venous access, therefore implantable venous ports are increasingly used. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Port-A-Cath
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- Nov 2025to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All breast cancer patients receiving right internal jugular venous port implantation in Gorgan medical centers (2017-2024).
Who may be able to join
- 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
Who cannot join
- Prior neck surgery or radiotherapy involving right jugular area
- Incomplete medical records
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
Chemotherapy is an essential component of breast cancer treatment. Frequent intravenous injections may lead to phlebitis and limited venous access, therefore implantable venous ports are increasingly used. The choice of port placement side in breast cancer patients is controversial, especially when mastectomy or radiotherapy is planned. This retrospective cohort study compares one-year patency, complications (infection, thrombosis, skin necrosis), and functional outcomes of ports implanted via the right internal jugular vein in patients with right versus left breast cancer.
Read the 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.
- Conditions
- Port-A-Cath
- Keywords
- chemotherapy, port, mastectomy, breast cancer, One-year patency
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
. One-year port patency
Defined as functional port access without removal due to complications
Measured: 12 months after port implantation
Secondary outcomes (4)
Infection
Incidence of port-related infection
Measured: 12 months
Thrombosis
Incidence of port-related thrombosis
Measured: 12 months
skin necrosis
incidence of skin necrosis
Measured: 12 months
cancer side association
Association between port side relative to cancer side and complication rates
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port-A-CathStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Golestan University of Medical sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pezhman Kharazm, MD, Golestan University of Medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197320
- Sponsor's protocol ID
- 115103
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data will not be shared because of patient privacy concerns and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07197320
- Acronym / sponsor ID
- 115103
- Conditions
- Port-A-Cath
- Keywords
- chemotherapy, port, mastectomy, breast cancer, One-year patency
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Golestan University of Medical sciencesUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 29 Sep 2025 (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.
Chemotherapy is an essential component of breast cancer treatment. Frequent intravenous injections may lead to phlebitis and limited venous access, therefore implantable venous ports are increasingly used. The choice of port placement side in breast cancer patients is controversial, especially when mastectomy or radiotherapy is planned. This retrospective cohort study compares one-year patency, complications (infection, thrombosis, skin necrosis), and functional outcomes of ports implanted via the right internal jugular vein in patients with right versus left breast cancer.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All breast cancer patients receiving right internal jugular venous port implantation in Gorgan medical centers (2017-2024).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Prior neck surgery or radiotherapy involving right jugular area
- Incomplete medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
. One-year port patency
Time frame: 12 months after port implantation
Defined as functional port access without removal due to complications
4 secondary outcomes
Infection
Time frame: 12 months
Thrombosis
Time frame: 12 months
skin necrosis
Time frame: 12 months
cancer side association
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: Undecided. The individual participant data will not be shared because of patient privacy concerns and institutional policies.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Port-A-Cath, run by Golestan University of Medical sciences at 1 site in Iran.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 29 Sep 2025. 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 Iran. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pezhman Kharazm (+989111751861, pezhmankh@goums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
. One-year port patency (time frame: 12 months after port implantation). 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 29 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.