Lymphedema Prevention With Facial Vein Preservation or Reconstruction During Neck Dissection for Operable Head & Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Lymphedema Staging
研究概览
简要总结
* The goal of this clinical trial is to learn if facial vein reconstruction after neck dissection works to reduce rates of lymphedema in adults getting surgical treatment for head and neck cancer.
This is a trial which aims to improve the rate of lymphedema for patients undergoing treatment for head and neck cancer. Our aim is to re-establish venous flow across the facial vein to improve lymphatic drainage after neck dissection.
- The investigators will also evaluate lymphatic flow before and after facial vein reconstruction to determine if there is evidence of lymphedema.
- The main questions this study aims to answer are:
- Does facial vein reconstruction after neck dissection improved lymphatic flow in head and neck cancer patients?
- Determine if there are changes in lymphatic flow before and after facial vein reconstruction?
After the study is completed, the investigators will compare rates of lymphedema and quality of life in patients with facial vein preservation/reconstruction as compared to previous patients treated for head and neck cancer without facial vein reconstruction.
Participants will undergo the following:
- Oncologic and reconstructive surgery as normal. No changes in cancer treatment will occur due to the study.
- When necessary, participants will undergo facial vein reconstruction immediately after neck dissection
- Visit the clinic once every 3 months for routine checkups and tests. This is typical for most patients treated for head and neck cancer including those not enrolled in the trial.
- Fill out short questionnaires to help understand quality of life after head and neck cancer treatment
- Undergo lymphography in the OR and at the 1-year mark in the office. This is a simple test performed without radiation exposure. It requires 3 very small skin injections to perform the test.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Ability to comply with the study protocol, including follow up visits and additional requirements for data collection
- •Ability to provide informed consent
- •Patients requiring unilateral or bilateral neck dissection. Patients must undergo at least three level neck dissection which must include level 1B
- •Patients will undergo radiotherapy +/-chemotherapy after surgery for HNC. Patients will be required to have adjuvant therapy after surgery to have similar risk of development of lymphedema.
- •No history of allergy to indocyanine green.
排除标准
- •Shellfish Allergy
- •Contraindication to surgery under general anesthesia
- •Prior head and neck surgery, radiation, or chemotherapy for HNC
- •Patients requiring sacrifice of the internal jugular vein or resection of neck skin for oncologic care
- •Anticipated partial or total laryngectomy
- •Pregnancy or lactation
研究组 & 干预措施
Facial Vein Reconstruction Group
When necessary, participants will get facial vein reconstruction immediately after neck dissection. Participants will also undergo lymphography before and after vein reconstruction. If the facial vein is intact, no intervention is needed, but the patient may still participate in the study.
干预措施: Facial Vein Reconstruction (Procedure)
结局指标
主要结局
Lymphedema Staging
时间窗: before surgery and every three months after surgery up to 1 year
The primary endpoint is the presence or absence of head and neck lymphedema (HNL) at follow-up, assessed using the MD Anderson Cancer Center Head and Neck Lymphedema (MDACC HNL) Scale. This scale is measured from 0 to 2. As the numbers increase, the severity of lymphedema increases. A score of 0 means there was no lymphedema present
次要结局
- internal lymphedema(before surgery and every 3 months after surgery up to 1 year)
- Head and Neck Lymphedema and Fibrosis Symptom Inventory(These will be performed before surgery and every 3 months after surgery up to 1 year)
- Indocyanine Green Near-infrared imaging(intraoperatively and at 1 year following surgery)
- The University of Washington Quality of Life(Before surgery and every 3 months up to 1 year after treatment.)
- The Functional Oral Intake Scale(Before surgery and every 3 months up to 1 year after treatment)
研究者
Shaum Sridharan
Associate Professor, Department of Otolaryngology - Head & Neck Surgery
University of Pittsburgh