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

18. august 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

37

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC Presbyterian Hospital and UPMC Shadyside Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lymphedema Staging
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
internal lymphedema
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. juli 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2026

Sidst verificeret

1. august 2026

Mere information

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