Lugol’s Iodine in surgical management of epithelial dysplasia in the oral cavity and oropharynx

ISRCTN	ISRCTN11348079
DOI	https://doi.org/10.1186/ISRCTN11348079
Protocol serial number	McCaul 01/2014
Sponsor	NHS Greater Glasgow and Clyde
Funder	Oracle Cancer Trust

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-lugols-iodine-during-surgery-to-remove-abnormal-cells-from-the-mouth-lister

Contact information

Prof Jim McCaul
Scientific

Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Phone	+44 (0)141 201 1100
Email	jmccaul@nhs.net

Miss Jacqueline Quantrill
Public

Bradford Institute for Health Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone	+44 1274 383921
Email	jacqueline.quantrill@bthft.nhs.uk

Study information

Primary study design	Interventional
Study design	Prospective multicentre phase III randomised controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Rates of surface dysplasia or carcinoma-in-situ at surface mucosal margins
Key secondary outcome measure(s)	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
Completion date	01/06/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
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

United Kingdom
England
Scotland

Study participating centres

London North West Healthcare Trust

Northwick Park Hospital
HA1 3UJ
United Kingdom

Bradford Royal Infirmary

Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

North Manchester General Hospital

The Pennine Acute Hospitals NHS Trust
D Block Square, Level 4
Delaunays Road, Crumpsall
Manchester
M8 5RB
United Kingdom

Ninewells Hospital and Dundee University Medicals

Dundee
DD1 9SY
United Kingdom

Queen Elizabeth Hospital

1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 1.2	27/02/2017	09/08/2022	No	No

Additional files

ISRCTN11348079_Protocol_v1.2_27Feb2017.pdf: Protocol file

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.