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

18 augustus 2026 bijgewerkt door: Shaum Sridharan, University of Pittsburgh

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

* 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

37

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • UPMC Presbyterian Hospital and UPMC Shadyside Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Facial Vein Reconstruction Group
When necessary, participants will get facial vein reconstruction immediately after neck dissection. Participants 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.
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Lymphedema Staging
Tijdsspanne: before 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
before surgery and every three months after surgery up to 1 year

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
internal lymphedema
Tijdsspanne: before surgery and every 3 months after surgery up to 1 year

We will utilize the Patterson Internal lymphedema scale to assess lymphedema during routine flexible laryngoscopy in the clinic. Patient will be undergoing flexible laryngoscopy as part of routine surveillance.

Several sites within the larynx and hypopharynx are graded as to the severity of edema(swelling). Each site is rated as none, mild, moderate, or severe edema.
before surgery and every 3 months after surgery up to 1 year
Head and Neck Lymphedema and Fibrosis Symptom Inventory
Tijdsspanne: These will be performed before surgery and every 3 months after surgery up to 1 year

The Head and Neck Lymphedema and Fibrosis Symptom Inventory (HNLEF) is the only validated symptom scale specific for HNL. HNLEF represents a 33 item survey around 7 domains of survivorship including soft tissue and neurologic toxicity, social functioning, oral dysfunction, body image, taste and swallowing, mucosal irritation, and communication. HNLEF has been shown to capture HNL-related symptom burden and functional impairments. Quality of life in regards to head and neck lymphedema are deemed worse with higher scores.

This tool contains 33 items (symptoms), which are answered in a "yes" or "no" format. If patients answer "yes" to any given item, they are then asked to rate the intensity of the respective symptom on a five-point scales. Each item then receives a score ranging from "0" (Does not experience the symptom) to "5" (Experiences the symptom with severe intensity). Scores can be examined with individual symptoms or based on average score for each subscale.
These will be performed before surgery and every 3 months after surgery up to 1 year
Indocyanine Green Near-infrared imaging
Tijdsspanne: intraoperatively and at 1 year following surgery

We will identify quality of head and neck lymphatic flow including disruption of lymphatic pathways and areas of pooling of indocyanine green.

Several observations will be recorded based on imaging. These will be deemed as present or absent without scale.

  • Presence of pooling demonstrating disrupted lymphatic pathways
  • Lymphatic escape pathways
  • Lymphatic flow across facial vein
  • Presence of lymphatic disruption not addressed by facial vein preservation/reconstruction
intraoperatively and at 1 year following surgery
The University of Washington Quality of Life
Tijdsspanne: Before surgery and every 3 months up to 1 year after treatment.
The University of Washington Quality of Life (UW-QOL Version 4) is a validated and reliable measure of physical and social-emotional QOL widely used in head and neck cancer. Twelve items assessing appearance, swallowing, chewing, speech, taste, saliva, pain, activity, recreation, shoulder function, mood, and anxiety are scored on a scale from 0 (worst possible response) to 100 (best possible response). Physical and social-emotional subscale scores range from 0 to 100, with higher scores indicating better QOL. A minimal clinically important difference (MCID) on the UW-QOL v4 subscales is generally considered to be approximately 5 points, representing a change that patients are likely to perceive as meaningful. A moderate clinically important change has been estimated at approximately 10 points, reflecting a more substantial improvement in patient-reported outcomes.
Before surgery and every 3 months up to 1 year after treatment.
The Functional Oral Intake Scale
Tijdsspanne: Before surgery and every 3 months up to 1 year after treatment
The Functional Oral Intake Scale (FOIS) can be utilized to measure oral intake ability before and after treatment. FOIS has been used across specialties and utilized a grading symptoms from 1-5. Level 1 indicates nothing taken orally; Level 2 indicates tube reliance with few attempts to take food or drinks orally; Level 3 indicates tube dependence with regular oral intake of food or liquids; Level 4 indicates a total oral diet but requires special preparations, compensations, or not expanded from whole-bottle feeding; and Level 5 indicates a total oral diet without special preparation. A higher score represents more swallowing disability
Before surgery and every 3 months up to 1 year after treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pittsburgh

Onderzoekers

  • Hoofdonderzoeker: Shaum Sridharan, M.D., Shaum Sridharan, Associate Professor, University of Pittsburgh Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 juli 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

3 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juli 2026

Eerst geplaatst (Werkelijk)

10 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

18 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY26010093

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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