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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Start date changed from estimate of Sep 2026 to Oct 3, 2026 · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 5 of 5 entries · 2 more Show 5 more changesShow less
    • Start date changed from estimate of Sep 2026 to Oct 3, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Notable Start date: Jul 2026 to Sep 2026v3
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
\* 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.
Trial Details
NCT Number NCT07694726
Lead Sponsor University of Pittsburgh
Conditions Head and Neck Cancer
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov