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Preventing Lymphedema After Head and Neck Cancer Surgery

This study is looking at a procedure called facial vein reconstruction to see if it can help prevent lymphedema (swelling caused by fluid buildup) in people having surgery for head and neck cancer. During neck dissection surgery, a vein in your face might be tied off. This study will repair that vein, possibly using a vein graft and a special connector, right after your neck dissection. Researchers want to see if repairing this vein helps improve the flow of lymphatic fluid and reduces the risk of lymphedema. They will measure lymphedema before surgery and for up to a year afterward. You may be able to join if you are an adult needing neck dissection and are in good general health.

Study design
This is an interventional study planning to enroll 37 participants. The study aims to understand if facial vein reconstruction improves lymphatic flow.
What's involved
You would have lymphedema staging measurements before surgery and every three months after surgery for up to one year. You would also need to attend follow-up visits and meet additional data collection requirements.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for lymphedema staging every three months after surgery for up to one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07694726

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

Not Yet Recruiting
NAAges 18+InterventionalTreatment
University of Pittsburgh
~37 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Facial Vein Reconstruction

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lymphedema Staging
Measured over before surgery and every three months after surgery up to 1 year

Conditions

Head and Neck Cancer

Explore related trials

Malignant Head and Neck Neoplasm

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Shaum Sridharan, M.D. · PRINCIPAL_INVESTIGATOR · Shaum Sridharan, Associate Professor, University of Pittsburgh Medical Center

Who to contact

Shaum S Sridharan, M.D.
[email protected]
412-647-2130
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Lymphedema Stagingbefore 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