Topic: Cancer, Ear, nose and throat
Conditions
Interventions
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
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed