Lymphovenous Anastomosis for Breast Cancer-related Lymphedema: A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Arm volume (Arm Circumferences)
研究概览
简要总结
This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment.
Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires.
Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months.
The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated.
The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research.
详细描述
This comprehensive single-armed cohort study is dedicated to assessing the effectiveness of lymphovenous anastomosis (LVA) in treating pitting lymphedema among adult female patients who have undergone breast cancer treatment.
This study builds upon findings from our preliminary pilot study at Odense University Hospital, and is conducted across several hospitalt in Denmark, including Odense University Hospital, Lillebælt Hospital Vejle, Zealand University Hospital Roskilde, and Herlev Hospital.
The study's primary aim is to determine whether LVA can significantly reduce arm volume and improve the overall quality of life for patients afflicted with breast cancer-related lymphedema.
Inclusion Criteria and Patient Recruitment The study population consists of women over 18 years of age suffering from unilateral arm lymphedema secondary to breast cancer treatment. Key eligibility criteria include active pitting lymphedema, presence of dermal backflow as evidenced by indocyanine green lymphography, identifiable lymphatic vessels in the affected arm, and the ability to provide informed consent and complete questionnaires in Danish.
Prospective participants are identified during clinical assessments at the participating hospitals' Departments of Plastic Surgery. Those deemed suitable for LVA surgery by consulting surgeons are invited to participate, ensuring informed consent through both oral and written communication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unilateral arm lymphedema secondary to breast-cancer treatment
- •Active pitting lymphedema
- •Presence of dermal backflow in indocyanine green lymphography
- •Identifiable lymphatic vessel(s) in the affected arm using an infrared camera and indocyanin green
- •Able to provide informed consent
- •Able to read, understand and complete Danish questionnaires
排除标准
- •Allergy to iodine
- •Pregnant, breast-feeding, or aiming to conceive withing the next year
- •History of bilateral breast cancer
研究组 & 干预措施
Lymphovenous anastomosis (LVA)
Intervention with lymphovenous anastomosis (LVA) surgery of the affected arm.
干预措施: Lymphovenous anastomosis (LVA) (Procedure)
结局指标
主要结局
Arm volume (Arm Circumferences)
时间窗: Baseline, six months, twelve months
Changes of arm volume difference
Arm volume (Water Displacement)
时间窗: Baseline, six months, twelve months
Changes of arm volume difference
次要结局
- Health-related quality of life (LYMPH-Q)(baseline, three months, six months, nine months, twelve months)
- General quality of life (SF-36)(baseline, three months, six months, nine months, twelve months)
- Arm and shoulder function (DASH)(baseline, three months, six months, nine months, twelve months)
- L-Dex(Baseline, six months, twelve months)
- LVA patency(Baseline, six months)
- Skin Fibrosis(Baseline, six months, twelve months)
- Surgery duration(Day of intervention)
- Body composition(Baseline, six months, twelve months)
- Skin Water Content(Baseline, six months, twelve months)
研究者
Caroline Lilja
MD
Odense University Hospital