Plain English Summary
Trial website
Contact information
Type
Public
Primary contact
Mr Pankaj Kumar Mishra
ORCID ID
http://orcid.org/0000-0002-0866-7825
Contact details
Department of Cardiothoracic Surgery
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
01642 850850
mishrapk_25@yahoo.com
Type
Scientific
Additional contact
Mr Joel Dunning
ORCID ID
Contact details
Department of Cardiothoracic Surgery
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
01642 850850
joedunning@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Lung Nodule Study Protocol : Version 1.1, 26th Feb 2015
Study information
Scientific title
A cohort study to investigate whether radiolabelled lung nodule localisation and excision is a technically successful and reliable method for excision, in patients with small lung nodule: a observational, prospective, pilot study
Acronym
Radio-labelled excision of lung nodules (RLELN)
Study hypothesis
Injection of small pulmonary nodules with radiolabelled material will improve accurate localisation, aid early resection of these nodules and will optimize patient management with resultant improved outcome.
Ethics approval
NRES Committee North West - Lancaster, 27/05/2015, ref: 15/NW/0369
Study design
Observational, prospective, pilot study
Primary study design
Observational
Secondary study design
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format. Please use the contact details below to request a patient information sheet.
Condition
Lung cancer or lung nodules of indeterminate origin
Intervention
Patients with very small nodules not amenable to excision via VATS surgery will be offered the option of radionucleotide injection of their nodules with VATS resection performed on the same day as an alternative to thoracotomy.
Patients will be identified from lung cancer multi-disciplinary (MDT) meetings. These MDT meetings are already an integral part of the researchers thoracic surgery services. They meet these patients to discuss their options for the management of these lung nodules and convey them the decision of the MDT. Patient makes a choice and an informed consent is taken. This new treatment option will be discussed as part of their treatment options.
The procedure will entail an admission to hospital (as per routine practice for patients who are due to undergo surgery). All patients will sign an informed consent form. They will have an injection of radio labelled substance under local anaesthesia by a consultant radiologist in the CT scan room. This is the same technique which is employed for CT guided lung biopsies which is a well-established procedure and the radiology team are well experienced in its conduct.
After this procedure the patient will return to the ward and later that day they will come to theatres, have a general anaesthetic and undergo a minimally invasive excision (key hole surgery) of the nodule in question.
The researchers will use the same key hole surgical technique that they routinely employ for larger nodules excision which they are able to see and feel, but the difference will be that they will use intraoperative gamma probe to detect the exact location of the nodule within the lung tissues. The recovery period from this operation will be about 2-4 days.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Technical success of lung nodule excision., assessed via histological confirmation of complete excision of nodule
Secondary outcome measures
1. Postoperative complications
2. Length of hospital stay
3. Conversion to Thoracotomy
Overall trial start date
10/12/2014
Overall trial end date
02/02/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients more than 16 years of age
2. Nodules less than 15 mm in size
3. Perceived difficulty in localising and excision of the nodule during surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Patients less than 16 years of age
2. Ability to remove mass without radiolabelling
3. Anatomic location of nodule makes it technically difficult to CT guided radiolabelling
4. Patient not willing to undergo the procedure
5. Inability to consent to the operation
6. Pregnancy
Recruitment start date
02/11/2015
Recruitment end date
02/02/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
James Cook University Hospital UK
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
James Cook University Hospital
Sponsor details
Research & Development Department
South Tees Hospitals NHS Foundation Trust
Academic Centre
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
01642 854089
Joe.Millar@stees.nhs.uk
Sponsor type
Research organisation
Website
Funders
Funder type
Hospital/treatment centre
Funder name
James Cook University Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The data from this study will be analysed and presented at national and International Meetings. The findings from the study will be published in peer reviewed journals.
Intention to publish date
01/11/2017
Participant level data
Not expected to be available
Results - basic reporting
Publication summary