Condition category
Cancer
Date applied
10/11/2015
Date assigned
01/04/2016
Last edited
24/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

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

Sponsor information

Organisation

London North West Healthcare NHS Trust

Sponsor details

Northwick Park Hospital
Harrow
HA1 3UJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review.