LISTER

• Research type

  Research Study

• Full title

  Lugol’s Iodine in Surgical Treatment of Epithelial Dysplasia in the Oral Cavity and Oropharynx

• IRAS ID

  187133

• Contact name

  Jim McCaul

• Contact email

  jmccaul@nhs.net

• Sponsor organisation

  London North West Healthcare NHS Trust

• ISRCTN Number

  ISRCTN11348079

• Duration of Study in the UK

  1 years, 6 months, 30 days

• Research summary

  When patients are referred with abnormal lining tissue (mucosa) in the mouth or throat which has been present for more than two weeks a sample of this tissue (a biopsy) is taken to assess the surface cells under the microscope. In these abnormal areas, there can be changes to the cells: this is called dysplasia. The cells can be slightly abnormal or very severely abnormal. If they are very severely abnormal, a cancer is more likely to develop from them in the future. This is why these changes are also referred to as precancerous changes. We know that removing these cells can reduce the risk of cancer developing. However it is often difficult for surgeons to see clearly where the abnormal tissue ends and normal tissue starts.

  Lugol’s iodine stain, which has been used as an antiseptic for many years, is used in some other parts of the body to help identify these precancerous cells. We think that this stain might help us to be more sure of removing all of the precancerous/abnormal cells and leaving behind the normal areas. There is evidence which suggests that if we do this, fewer patients will develop cancer after surgery and so more will be successfully treated.

  Consenting patients will be randomised to either of the following treatment groups:

  1. Standard Treatment Group – Surgical excision as per usual practice
  2. Intervention Treatment Group – Surgical excision assisted by visualisation with Lugol’s iodine

  We will compare the rates of dysplasia at the edges of the samples in each group. We will also assess how much normal tissue next to the precancer tissue is removed. This will allow us to assess whether this method is effective in helping us to more accurately remove dysplastic tissue.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  16/LO/0857

• Date of REC Opinion

  27 Jul 2016

• REC opinion

  Further Information Favourable Opinion