Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Th2 Cytokine Levels
研究概览
简要总结
The goal of this clinical research study is to measure the amount of inflammatory proteins inside the body before and after lymphatico-venular bypass surgery. This will help doctors learn if anti-fibrotic or anti-inflammatory drugs/treatments given with the surgery can improve how well the surgery works.
详细描述
If you choose to take part in this study, you will have 1 small piece of tissue (about the size of a pencil eraser) collected from the arm with the lymphedema and another small piece of tissue will be collected from the unaffected arm. A total of 4 samples will be collected by excisional biopsy (2 samples before the surgery and 2 more samples again 6 months after the surgery). To collect an excisional biopsy, the area of skin is numbed with anesthetic and a small cut is made to remove all or part of the affected tissue.
Blood (about 5 teaspoons each time) will also be drawn before the surgery and 1 more blood sample again 6 months after the surgery. If possible, the blood samples will be collected during already scheduled blood draws to avoid additional needle sticks.
The tissue and blood samples will be used for testing to evaluate the level of the tissue inflammation and to check for any build-up of excess tissue.
Length of Study:
After both tissue and blood samples have been collected, your participation in this study will be over.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing lymphatico-venular bypass for lymphedema.
- •History of axillary lymph node dissection, sentinel lymph node biopsy or dissection.
- •A minimum of three (3) months post-op from any surgical interventions.
- •A minimum of six (6) months from the last dose of chemotherapy.
- •Patients with unilateral lymphedema.
排除标准
- •Active systemic infection or allergic reaction.
- •Active parasitic infection.
- •History of primary (congenital) lymphedema.
- •Metastatic cancer.
- •History of autoimmune disorders including lupus, rheumatoid arthritis, vasculitis, systemic sclerosis.
- •History of other fibroproliferative disorders including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis, scleroderma.
- •Current treatment with steroids.
- •Concurrent secondary systemic cancer exclusive of cutaneous malignancies.
- •Treatment with myelosuppressive or stimulatory drugs within six (6) months of enrollment.
- •History of bone marrow transplantation.
结局指标
主要结局
Th2 Cytokine Levels
时间窗: 6 months
5 mm punch biopsy specimens from the affected, lymphedematous limb will be obtained just prior to lymphatico-venular bypass and six (6) months after lymphatico-venular bypass. Punch biopsies will be obtained from the radial (lateral) aspect of the upper arm approximately 10cm above the olecranon process. Biopsy specimens will be collected from the contralateral (normal) arm at the exact same location.
次要结局
未报告次要终点