Real time ultrasound elastography in the investigation of thyroid nodules and the diagnosis of thyroid cancer

ISRCTN	ISRCTN18261857
DOI	https://doi.org/10.1186/ISRCTN18261857
IRAS number	142485
Secondary identifying numbers	CPMS 17373, IRAS 142485

Submission date: 28/01/2015
Registration date: 28/01/2015
Last edited: 17/10/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-a-new-way-of-testing-thyroid-nodules-to-see-if-they-are-cancerous-or-not-elation

Study website

Contact information

Mr Andrew Palmer
Scientific

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

Phone	+44 (0)121 415 9965
Email	a.palmer@bham.ac.uk

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The efficacy and cost effectiveness of real time ultrasound elastography in the investigation of thyroid nodules and the diagnosis of thyroid cancer
Study acronym	ElaTION
Study objectives	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(s)	NREC Committee South Central- Berkshire, 10/10/2014, ref: 14/SC/1206
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	20/11/2014
Completion date	30/09/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 968; UK Sample Size: 968
Total final enrolment	982
Key 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 years or over 3. Patient able and willing to give written informed consent
Key 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
Date of first enrolment	27/02/2015
Date of final enrolment	30/09/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clinical Trials Unit (University of Birmingham)

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham
University/education

Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/03/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
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 5.0	18/11/2016	09/01/2023	No	No
HRA research summary			28/06/2023	No	No
Results article		01/08/2024	10/09/2024	Yes	No
Results article	Evaluation of US elastography	15/10/2024	17/10/2024	Yes	No

Additional files

ISRCTN18261857 elation-protocol-v5.0-18-nov-2016-final.pdf

Editorial Notes

17/10/2024: Publication reference added.
11/09/2024: Total final enrolment added.
10/09/2024: Publication reference added.
09/01/2023: The following changes have been made:
1. The overall trial end date has been changed from 31/03/2023 to 30/09/2022.
2. Protocol file uploaded.
2. IRAS number added.
16/03/2022: The overall trial end date has been changed from 31/03/2022 to 31/03/2023.
28/04/2021: The overall trial end date has been changed from 30/03/2020 to 31/03/2022.
12/10/2018: Intention to publish date added.
12/01/2018: The recruitment end date has been updated from 30/11/2017 to 30/09/2018. The overall trial end date has been updated from 30/11/2017 to 30/03/2020.
14/02/2017: The following changes have been made to the record:
1. The target number of participants has been updated from 1000 to 968
2. Within "the last 6 months" has been added to the first inclusion criteria and exclusion criteria
3. The outcome measures have been updated
30/11/2016: The study contact has been changed from Mrs Sarah Khan to Mr Andrew Palmer.