Contact information
Type
Scientific
Primary contact
Mr Andrew Palmer
ORCID ID
Contact details
Birmingham Clinical Trials Unit (BCTU)
Institute of Applied Health Research
College of Medical and Dental Sciences
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 121 415 9965
a.palmer@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17373
Study information
Scientific title
The efficacy and cost effectiveness of real time ultrasound elastography in the investigation of thyroid nodules and the diagnosis of thyroid cancer
Acronym
ElaTION
Study hypothesis
The aim of this study is to compare the use of real time elastography (RTE) in conjunction with ultrasound to guide fine needle aspiration cytology FNAC (the intervention) with conventional ultrasound-only guided FNAC (current practice–comparator).
Ethics approval
NREC Committee South Central- Berkshire, 10/10/2014, ref: 14/SC/1206
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Cancer, Ear, nose and throat; Subtopic: Head and Neck Cancer, Ear (all Subtopics); Disease: Endocrine, Head and Neck
Intervention
Intervention arm- Real-time ultrasound elastography – guided FNAC. RTE is a technology that can be added at the same time as the routine ultrasound examination, and may help differentiate benign from malignant nodules based on the compression characteristics of the two.; Follow Up Length: 12 month(s)
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Primary outcome measure as of 14/02/2017:
The proportion of patients who have a non-diagnostic (Thy1) cytology result following the first FNAC.
Original primary outcome measure:
The rate of benign histology result following thyroid surgery, compared between the RTE-FNAC arm and the conventional US-FNAC arm.
Secondary outcome measures
Secondary outcome measures as of 14/02/2017:
1. Number of FNACs required to obtain definitive diagnosis
2. Time from first FNAC to obtaining a definitive diagnosis
3. The proportion of patients with benign histology results following thyroidectomy
4. Proportion of patients who have thyroidectomy
5. Accuracy of a cytology results for first FNAC and repeated FNAC in relation to overall definitive diagnosis;
6. Accuracy of an imaging assessment on ultrasound (with or without RTE) alone diagnostic protocol in relation to overall definitive diagnosis
7. Patient reported outcome measures of depression and anxiety, pain, and quality of life: the Hospital Anxiety and Depression rating scale (HADS), Visual Analogue Pain Score (VAPS) and EQ-5D quality of life score
8. Radiologist report of whether RTE had contributed to the radiologist’s decisions, how easy they found using RTE, and whether they found it helpful above using US-alone in predicting malignancy
9. Complication rate from any thyroidectomy at 30-days and 6-months post-surgery – to include haematoma and temporary hypocalcaemia rate at 30 days and vocal cord palsy and permanent hypocalcaemia at 6 months post-operative
10. Resource usage for consultant time and diagnostic testing procedures and subsequent management including consultations and surgical treatments
Original secondary outcome measures:
1. Overall number of FNAC's Required and time to obtain a definitive diagnosis in each arm
2. Non-diagnostic cytology (Thy1) rate for the first FNAC undertaken in each patient
3. Resource use for consultation time and diagnostic testing procedures and quality of life (EQ-5D)
4. Predictive value of a benign (Thy2) cytology results for first FNAC and repeated FNAC in relation to overall definitive diagnosis for RTE-FNAC and conventional US-FNAC
5. Patients reported anxiety immediately before and after US FNAC, immediately before each consultation for results of US FNA or surgery and at 6 and 12 months from initial US FNAC
6. Radiologist survey-completed by Radiologists at the end of the procedure to identify whether radiologists found US or RTE had contributed to their decision, ease of use, and their prediction of malignancy of the nodule using RTE or US features alone
7. Agreement rates for RTE between local operator and RTE or US features alone
8. Patient reported pain (by Visual analogue score) at procedure
9. Complication rate from any thyroidectomy- haematoma rate, vocal cord palsy at 6 months, permanent hypocalcaemia rate at 6 months
10. Cost-benefit analysis
Overall trial start date
20/11/2014
Overall trial end date
30/11/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with single or multiple thyroid nodules whether solid, cystic or mixed, undergoing investigation who have not undergone previous FNAC within the last 6 months
2. Aged 18 or over
3. Patient able and willing to give written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 968; UK Sample Size: 968
Participant exclusion criteria
1. Patients who have undergone previous thyroid FNAC in the last 6 months.
2. Patients with a bleeding diathesis that precludes FNAC
3. Patients with a needle phobia.
4. Pregnant patients
5. Patients with purely cystic nodules or with recent haemorrhage, with no solid component
Recruitment start date
27/02/2015
Recruitment end date
30/11/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Trials Unit (University of Birmingham)
Edgbaston
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary