Facial Vein Reconstruction to Prevent Lymphedema After Neck Surgery for Head and Neck Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines facial vein reconstruction performed during or after neck dissection in adults with head and neck cancer. Researchers will compare lymphatic flow before and after reconstruction and track lymphedema rates and quality of life. The study includes patients who will receive adjuvant radiotherapy or chemoradiation and requires at least a three-level neck dissection that includes level 1B. Outcomes focus on lymphatic drainage, lymphedema incidence, and patient-reported quality of life. Safety and feasibility of this surgical approach will also be evaluated.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Where it's running

• UPMC Presbyterian Hospital and UPMC Shadyside Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Shaum Sridharan, M.D. — Shaum Sridharan, Associate Professor, University of Pittsburgh Medical Center
• Study coordinator: Shaum S Sridharan, M.D.
• Email: sridharans2@upmc.edu
• Phone: 412-647-2130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.