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

NCT07694726 | Not Yet Recruiting DMC

• 1 other identifier: STUDY26010093
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

\* 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:
• Does facial vein reconstruction after neck dissection improved lymphatic flow in head and neck cancer patients?
• Determine if there are changes in lymphatic flow before and after facial vein reconstruction?
• Oncologic and reconstructive surgery as normal. No changes in cancer treatment will occur due to the study.
• When necessary, participants will undergo facial vein reconstruction immediately after neck dissection
• 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.
• Fill out short questionnaires to help understand quality of life after head and neck cancer treatment
• 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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; head and neck lymphedema; lymphedema

Outcome Measures

Primary Outcomes (1)

• Lymphedema Staging

  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

Secondary Outcomes (5)

• internal lymphedema

  before surgery and every 3 months after surgery up to 1 year

• Head and Neck Lymphedema and Fibrosis Symptom Inventory

  These will be performed before surgery and every 3 months after surgery up to 1 year

• Indocyanine Green Near-infrared imaging

  intraoperatively and at 1 year following surgery

• The University of Washington Quality of Life

  Before surgery and every 3 months up to 1 year after treatment.

• The Functional Oral Intake Scale

  Before surgery and every 3 months up to 1 year after treatment

Study Arms (1)

Facial Vein Reconstruction Group

EXPERIMENTAL

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

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.

Facial Vein Reconstruction Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Presbyterian Hospital and UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Raad RA, Obuekwe F, Smith JD, Berry J, Chinn SB, Spector BE, Maxwell J, Kim S, Zevallos JP, Contrera KJ, Sridharan SS, Nilsen ML, Spector ME. Facial Vein Ligation is Associated with Lymphedema Among Patients with Head and Neck Cancer Undergoing Surgery and Radiation. Ann Surg Oncol. 2026 Mar;33(3):2485-2492. doi: 10.1245/s10434-025-18669-9. Epub 2025 Nov 1.

  PMID: 41175182 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Shaum Sridharan, M.D.

  Shaum Sridharan, Associate Professor, University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaum S Sridharan, M.D.

CONTACT

412-647-2130; sridharans2@upmc.edu

Sridharan

CONTACT

5126989399; sridharans2@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Otolaryngology - Head & Neck Surgery

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)