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

    richard.shaw@liverpool.ac.uk

  • 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