ELaTION trial

ELaTION:

The Rationale for a Trial

Palpable throid nodules can be detected in about 5-7% of the population. According to the British Thyroid Association guidelines, definitive investigation of thyroid nodules is by ultrasound and fine needle aspiration cytology. Using US, nodularity of the throid can be detected in upto 50% of the population and approximately 4-7% of the thyroid nodules are malignant.

Due to the use of imaging modulaties, incidental throid nodules which are asymptomatic are increasing, being detected and investigated, resulting in an increase burden for the NHS and patients.

Real Time Ultrasound (RTE) is a recently developed technology that can be used as an adjunct to US- guided FNAC. RTE combines the diagnostics advantages of US-FNAC with an assessment of the stiffness of the nodule to increase the accuracy of thyroid cancer diagnosis.

In view of conflicting results from some of the retrospective and prospective case series and the fact that most results are single institution reports, a RCT is required to provide evidence of the role of RTE in the diagnosis of thyroid nodules. If proven effective in reducing the false positive rates and the need for FNAC it has the potential to reduce healthcare costs and patient distress significantly. In addition, ElaTION will attempt to answer some of the important outstanding questions in thyroid ultrasonography mainly the efficacy of ultrasound- only protocols and the need for repetition of Thy2 US FNAC in the diagnosis of thyroid nodules,

The aim of ElaTION is to determine if Real Time Ultrasound (RTE) Guided FNAC reduces the number of patients who have a non-diagnostic first FNAC result, compared to conventional ultrasound only guided FNAC.

Trial Design

ElaTION is a pragmatic, multi centre randomised controlled trial (RCT)

Eligible participants will be randomised to either the Real-time ultrasound elastography (RTE) in conjuction with fine needle aspiration cytlogy (FNAC) or Ultrasound (US) only guided FNAC.

small-schema

The trial aims to randomise 968 patients durng the course of 3 years.

Objectives

 

Primary objective:

 

  • To determine if RTE in conjuction with fine needle aspiration cytology will reduce the number of patients with who have a non-diagnostis first FNAC result as compared to conventional ultrasound only guided FNAC.

Secondary objectives:

  • Whether RTE compared to US reduces the total number of FNACs required to reach a definitive diagnosis;
  • Whether RTE compared to US reduces the time from first FNAC assessment until definitive diagnosis;
  • Whether RTE compared to US reduces the false positive rate i.e. the number of patients who receive a benign histology following surgery;
  • Whether RTE compared to US reduces the non-diagnostic (Thy 1) rate following all FNAC;
  • Whether RTE compard to US reduces the number of patients having thyroidectomy;
  • Whether ultrasound alone is an accurate diagnostic modality for malignant thyroid nodules;
  • Whether RTE and US without FNAC is as accurate as RTE or US with FNAC;
  • Whether patients' anxiety, quality of life and patient reported procedural pain are improved using RTE-FNAC compared to US-FNAC;
  • The value of RTE in radiologist decision making an undertaking of FNAC;
  • Complication rates of thyroidectomy;
  • Whether RTE-FNAC is cost-effective compared to current practice of US-FNAC.

Outcome Measures

Primary outcomes:

  • The proportion of patients who have a non-diagnostic (Thy1) cytology result following the first FNAC.

Secondary outcomes:

  • Number of FNACs required fo obtain a definitive diagnosis*;
  • Time from first FNAC to obtaining a definitive diagnosis;
  • The proportion of patients with benign histology results following thyroidectomy;
  • Proportion of patients who have thyroidectomy;
  • Accuracy of a cytology result for the first FNAC and repeated FNAC in relation to overall definitive diagnosis;
  • Accuracy of an imaging assessment on ultrasound (with or without RTE) alone diagnostic protocol in relation to overall definitive diagnosis;
  • 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;
  • 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;
  • Complication rate from any thyroidectomy at 30-days and 6-months post-surgery - to include haematoma rate and temporary hypocalcaemia rate at 30 days and vocal cord palsy and permanent hypocalcaemia at 6 months post-operative;
  • Resource usage for consultation time and diagnostis testing procedures and subsequent management including consultations and surgical treatments.

Randomisation

To randomise a patient please call 0800 953 0274

ElaTION Study Office

Email: elation@trials.bham.ac.uk

Laura Magill (Trial Manager) Tel: 0121 415 9105 Email: e.l.magill@bham.ac.uk

Andy Palmer (Trial Coordinator) Tel: 0121 415 9965 Email: a.palmer@bham.ac.uk

Mike Walters (Data Manager) Tel: 0121 415 9965 Email: m.walters@bham.ac.uk