Outcomes following neck surgery in oral cancer V1
Research type
Research Study
Full title
Outcomes following neck surgery in oral cancer V1: Understanding the contribution of sentinel node biopsy
IRAS ID
199671
Contact name
Richard J Shaw
Contact email
Sponsor organisation
Liverpool Joint Research Office
Clinicaltrials.gov Identifier
(no ref number), BAOMS
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Outcomes following neck surgery in oral cancer: Understanding the contribution of sentinel node biopsy
20 to 30% of patients with early oral cancer (T1/T2 N0) have cancer in the lymph nodes in the neck that cannot be found clinically or radiologically (occult metastasis). Treatment of these patients is controversial. Evidence suggests an operation to remove most of the lymph nodes from the neck (elective neck dissection-END)improves survival. As it is not possible to identify which patients have occult metastasis before surgery, 70 to 80% of patients will not benefit but will be exposed to its risks. These include 3 to 4 days in hospital, bleeding, a large scar and occasionally shoulder weakness and stiffness.
Cervical Sentinel lymph node biopsy (SLNB) is a smaller operation than END. It aims to identify the first lymph nodes in the neck tumour would spread to and remove only them. It is already used in breast cancer and melanoma and is recommended by NICE for early oral cancer. It is though that as SLNB is a smaller operation it may give better functional, health related quality of life and patient reported outcomes than END. However there is little evidence showing this. Our study will compare patients who have had END and SLNB to see if differences can be demonstrated.
The study will run at Aintree University Hospital, Queen Elizabeth Hospital Glasgow and Guys Hospital London. Eligible patients will have undergone surgical treatment for T1/T2 N0 oral cancer at least 6 months previously and had either END or SLNB. Consenting patients will be invited to a single research clinic. Shoulder movement will be assessed by a physiotherapist, HRQoL by questionnaires, and scar by photographs. Patients that are not able to attend clinics but wishing to be involved will be sent questionnaires in the post.REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0419
Date of REC Opinion
27 Aug 2018
REC opinion
Further Information Favourable Opinion