Lugol’s Iodine in surgical management of epithelial dysplasia in the oral cavity and oropharynx
| ISRCTN | ISRCTN11348079 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11348079 |
| Secondary identifying numbers | McCaul 01/2014 |
- Submission date
- 10/11/2015
- Registration date
- 01/04/2016
- Last edited
- 09/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
| Phone | +44 (0)141 201 1100 |
|---|---|
| jmccaul@nhs.net |
Public
Bradford Institute for Health Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
| Phone | +44 1274 383921 |
|---|---|
| jacqueline.quantrill@bthft.nhs.uk |
Study information
| Study design | Prospective multicentre phase III randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | LISTER |
| Study objectives | 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(s) | London-Harrow Research Ethics Committee, 13/10/2016, ref: 16/LO/0857 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2014 |
| Completion date | 01/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 (to increase to 388 after initial feasibility) |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/12/2015 |
| Date of final enrolment | 01/12/2018 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
HA1 3UJ
United Kingdom
Bradford
BD9 6RJ
United Kingdom
D Block Square, Level 4
Delaunays Road, Crumpsall
Manchester
M8 5RB
United Kingdom
DD1 9SY
United Kingdom
Glasgow
G51 4TF
United Kingdom
Sponsor information
Hospital/treatment centre
West Glasgow Ambulatory Care Hospital
Dalnair Street
Glasgow
G3 8SW
Scotland
United Kingdom
"ROR" |
https://ror.org/05kdz4d87 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.2 | 27/02/2017 | 09/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
09/08/2022: Protocol file uploaded.
26/05/2021: Internal review.
13/07/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2018 to 01/12/2018.
2. The overall trial end date was changed from 01/12/2018 to 01/06/2019.
3. The intention to publish date was added.
31/10/2017: Internal review.
27/07/2017: Ethical approval was added.
25/07/2017: Miss Kayleigh Gilbert (kayleigh.gilbert@nhs.net) has been removed as a study contact. Ms Jacqueline Quantrill has been added as a study contact. Mr McCaul's institutional address has been changed from Northwick Park Hospital to Queen Elizabeth University Hospital. Overall trial end date has been changed from 01/12/2016 to 01/12/2018. Recruitment end date has been changed from 01/06/2016 to 01/06/2018. Four trial participating centres have been added (Bradford Royal Infirmary, The Pennine Acute Hospitals NHS Trust North Manchester General Hospital, Ninewells Hospital and Dundee University Medicals, Queen Elizabeth Hospital. The Royal Marsden Hospital has been removed as a trial participating site. The study sponsor has been changed from London North West Healthcare NHS Trust to NHS Greater Glasgow and Clyde.
21/12/2016: Cancer Help UK lay summary link added.
