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* 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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial Vein Reconstruction Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| internal lymphedema | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaum S Sridharan, M.D. | Contact | 412-647-2130 | sridharans2@upmc.edu | |
| Sridharan | Contact | 5126989399 | sridharans2@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shaum Sridharan, M.D. | Shaum Sridharan, Associate Professor, University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Hospital and UPMC Shadyside Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41175182 | Background | 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. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| Head and Neck Lymphedema and Fibrosis Symptom Inventory | 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 | 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.
| intraoperatively and at 1 year following surgery |
| The University of Washington Quality of Life | 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 | 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 |