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
Contact information
Mr Andrew Palmer
Scientific
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 |
|---|---|
| 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 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(s) | NREC Committee South Central- Berkshire, 10/10/2014, ref: 14/SC/1206 |
| 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 |
| 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 |
| Overall study end 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 |
| 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 years or over 3. Patient able and willing to give written informed consent |
| 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 | 30/09/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Trials Unit (University of Birmingham)
Edgbaston
Birmingham
B15 2TT
United Kingdom
Birmingham
B15 2TT
United Kingdom
Sponsor information
University of Birmingham
University/education
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
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
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.
