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临床试验/NCT07197320
NCT07197320尚未招募不适用

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)

Golestan University of Medical sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
. One-year port patency

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Prior neck surgery or radiotherapy involving right jugular area
  • •Incomplete medical records

结局指标

主要结局

. One-year port patency

时间窗: 12 months after port implantation

Defined as functional port access without removal due to complications

次要结局

  • skin necrosis(12 months)
  • Infection(12 months)
  • Thrombosis(12 months)
  • cancer side association(12 months)

研究者

发起方
Golestan University of Medical sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pezhman Kharazm, MD

Assistant Professor of Vascular Surgery

Golestan University of Medical sciences

研究点 (1)

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