Contact information
Type
Scientific
Primary contact
Prof Jim McCaul
ORCID ID
Contact details
Head & Neck Research
R&D Dept. Level 7 Maternity Block
London North West Healthcare NHS Trust
Northwick Park Hospital
Watford Road
London
HA1 3UJ
United Kingdom
02088693928
jmccaul@nhs.net
Type
Public
Additional contact
Miss Kayleigh Gilbert
ORCID ID
Contact details
Head & Neck Research
R&D Dept
Level-7
Maternity Block
London
HA1 3UJ
United Kingdom
02088693928
kayleigh.gilbert@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
McCaul 01/2014
Study information
Scientific title
A multi-centre, randomised controlled trial assessing the effectiveness of Lugol's Iodine in Surgical managemenT of Epithelial dysplasia in the oRal cavity and oropharynx
Acronym
LISTER
Study hypothesis
Does intraoperative visualisation of dysplastic mucosa with Lugol’s Iodine assist in improving accuracy of excision of epithelial dysplasia of oral cavity and oropharynx
Ethics approval
Not provided at time of registration
Study design
Prospective multicentre phase III randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Epithelial dysplasia in the oral cavity and oropharynx
Intervention
1. Standard Treatment Group: Surgical excision of epithelial dysplasia as per usual practice
2. Intervention Treatment Group: Surgical excision of epithelial dysplasia assisted by visualisation with Lugol’s iodine
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Rates of surface dysplasia or carcinoma-in-situ at surface mucosal margins
Secondary outcome measures
1. Two-year incidence of histologically confirmed transformation to SCC in the oral/cavity/oropharynx
2. Occult SCC diagnosed histopathologically in excised mucosa
3. Surface area of mucosa excised
4. Extent of margin clearance in mm
5. Surgeon decision to re-excise at the same site following positive margins
6. Estimate of the two year recurrence rates of oral dysplasia
7. Acceptability of the technique to surgeons (intervention treatment group)
8. Safety of the technique (intervention treatment group)
9. Assessment of Quality of Life changes
Overall trial start date
01/01/2014
Overall trial end date
01/12/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Provision of written informed consent
2. Age≥ 18 years old
3. Epithelial dysplasia of the oral cavity or oropharynx, undergoing primary surgical excision under general anaesthesia
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 (to increase to 388 after initial feasibility)
Participant exclusion criteria
1. Previous surgery or radiotherapy for head and neck cancer
2. Allergy to iodine
3. Previous diagnosis of head & Neck SCC in the past 5 years or active malignancy within 2 years of randomisation (except basal cell carcinoma or carcinoma of the cervix in-situ)
Recruitment start date
01/12/2015
Recruitment end date
01/06/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
London North West Healthcare Trust
Northwick Park Hospital
HA1 3UJ
United Kingdom
Trial participating centre
Royal Marsden Hospital
SW3 6JJ
United Kingdom
Funders
Funder type
Charity
Funder name
Oracle Cancer Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The findings will be disseminated locally at clinical governance meetings, at national and international head and neck cancer scientific meetings (BAOMS, BAHNO, IAOO). We will take advice from our local patient research forum on how to best reach the local population with the findings. We aim to publish the findings in the British Journal of Oral and Maxillofacial Surgery within six months of the final patient visit.
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary