Utility of a Second Ultrasound-guided Fine Needle Aspiration for the Detection of Thyroid Cancer in the Management of Single Thyroid Nodules or Multinodular Goitre.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Status nodule
Study Overview
Brief Summary
Thyroid nodules are common (prevalence of 12.7% in women), but are malignant in only 5% of cases. International experts agree that a preliminary cytological examination by fine needle aspiration (FNA) is required. The management of patients with cytological results consistent with malignant or suspicious for malignancy nodules is well codified and generally involves surgery. However, there is no consensus concerning 1) the utility of a second FNA during the monitoring of benign nodules. Certain studies have recommended a second FNA, whereas others have recommended ultrasound monitoring alone; 2) the contribution of ultrasound criteria to the decision as to whether to carry out a second FNA, particularly if the nodule increases in size; 3) the management of nodules classified as doubtful or suspect on needle biopsy, many of which prove to be benign (20 to 30% are malignant), raising questions about the utility of systematic thyroid surgery or the justification for a second FNA; 4) the management of patients with non significant (NS) findings on FNA, for whom immediate surgery, monitoring or a second FNA may be recommended and 5) the procedure to be followed for nodules present in patients with multinodular thyroid disease.
Detailed Description
Background :
A few studies have tried to evaluate the value of a second needle biopsy. Ultrasound criteria for malignancy have been described but are mostly unvalidated. Only a very small number of immunocytochemical studies using several antibodies have been reported, mostly dealing with series of less than 50 cases. The Bethesda State of Science Conference held in October 2007 (ahead on print, 2009) on fine-needle biopsy of the thyroid considered that no sufficiently robust studies of this technique had yet been carried out and that prospective studies were required.
Objectives:
The principal objective of this study is to determine the utility of a second needle biopsy in the routine management of patients presenting, for a given nodule, initial cytological results that were non-significant, benign, doubtful or suspect. The secondary objectives are to determine the utility of various pre-determined ultrasound criteria and of the collection of cells in liquid medium combined with immunocytochemistry.
Methodology:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient are more than 18 years old
- •Patient with a unique or several thyroid solid nodules more than 10 mm wide
- •Patient who accept to be followed over 18 months
- •Study Informed patient, non opposed to his/her own data analyzes
Exclusion Criteria
- •Pregnant women
- •Patient with previous data of thyroid cancer
- •Patient with low TSH (inferior to local norm)
- •Patient refusing thyroid surgery policy/ rule
- •Irresponsible patient or patient refusing to participate
- •Patient with clinical or psychological state not permitting study sample
Outcomes
Primary Outcomes
Status nodule
Time Frame: Inclusion, 6, 12 and 18 months
Secondary Outcomes
No secondary outcomes reported