Preventing Lymphedema in Patients Undergoing Surgical Treatment for Head and Neck Cancer Through Vein Reconstruction

Официальное название

Lymphedema Prevention With Facial Vein Preservation or Reconstruction During Neck Dissection for Operable Head & Neck Cancer

Обзор

\* 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: 1. Does facial vein reconstruction after neck dissection improved lymphatic flow in head and neck cancer patients? 2. 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: 1. Oncologic and reconstructive surgery as normal. No changes in cancer treatment will occur due to the study. 2. When necessary, participants will undergo facial vein reconstruction immediately after neck dissection 3. 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. 4. Fill out short questionnaires to help understand quality of life after head and neck cancer treatment 5. 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.

Вмешательства

• Процедура Facial Vein Reconstruction
  Immediately after neck dissection, the facial vein will be assessed. If the vein has been ligated for the neck dissection, then the vein will be repaired. This may require vein graft and the use of a venous coupler. If the vein is intact after neck dissection, we can proceed without surgical intervention.

Первичные конечные точки

• Lymphedema Staging [Срок оценки: before surgery and every three months after surgery up to 1 year]

Вторичные конечные точки (5)

• internal lymphedema [Срок оценки: before surgery and every 3 months after surgery up to 1 year]
• Head and Neck Lymphedema and Fibrosis Symptom Inventory [Срок оценки: These will be performed before surgery and every 3 months after surgery up to 1 year]
• Indocyanine Green Near-infrared imaging [Срок оценки: intraoperatively and at 1 year following surgery]
• The University of Washington Quality of Life [Срок оценки: Before surgery and every 3 months up to 1 year after treatment.]
• The Functional Oral Intake Scale [Срок оценки: Before surgery and every 3 months up to 1 year after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UPMC Presbyterian Hospital and UPMC Shadyside Hospital — Pittsburgh

Публикации

• Raad RA, Obuekwe F, Smith JD, Berry J, Chinn SB, Spector BE, Maxwell J, Kim S, Zevallos JP, Contrera KJ, Sridharan SS, Nilsen ML, Spector ME. Facial Vein Ligation is Associated with Lymphedema Among Patients with Head and Neck Cancer Undergoing Surgery and Radiation. Ann Surg Oncol. 2026 Mar;33(3):2485-2492. doi: 10.1245/s10434-025-18669-9. Epub 2025 Nov 1. PMID 41175182

Идентификаторы

NCT: NCT07694726 · STUDY26010093

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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