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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07694726
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Facial Vein Reconstruction — PROCEDURE
    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.

Study Details

\* 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. * We 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. Can we see changes in lymphatic flow before and after facial vein reconstruction? After the study is completed, we 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, patients 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 us 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.

Key Dates

First listed
Jul 10, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Facial Vein Reconstruction Group
    When necessary, patients will get facial vein reconstruction immediately after neck dissection. They 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.

Primary Outcome Measure

Lymphedema Staging [ Time Frame: before surgery and every three months after surgery up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Presbyterian Hospital and UPMC Shadyside HospitalPittsburghPennsylvania15213
Shaum S Sridharan, M.D.
[email protected]
412-647-2130

Find similar trials in Pittsburgh, PA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
UPMC Presbyterian Hospital and UPMC Shadyside Hospital· Pittsburgh, PA

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