Comparison of outcome with three different needles in ultrasound assisted fine needle aspiration cytology (FNAC) of the thyroidal gland.

Comparison of outcome with three different needles in ultrasound assisted fine needle aspiration cytology (FNAC) of the thyroidal gland. - FAMA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37029

Enrollment

336

Registered

2012-12-19

Start date

2013-01-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benigne and maligne nodules of the thyroid gland

Interventions

Patients will undergo a FNAC of the thyroidal gland the same way as other patients who will not participate in this study. The only difference is that there is a possibility another needle will be u

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with a thyroid nodule on ultrasound Age greater than 18 Ability to give written informed consent

Exclusion criteria

Exclusion criteria: Patient refusal

Design outcomes

Primary

Measure	Time frame
The main study parameter is to achieve a higher percentage of diagnostical-results. This goal will be achieved when the percentage diagnostical-result will increase. Because of the low current percentage diagnostical-result comparing to the national percentage mentioned in literature, the investigators wish to achieve an increased percentage of 5%. In this case the new percentage diagnostical-results will be 81%, and the investigators will speak of clinical relevance. Off course the higher the outcome, the better it will be for the patients. During the ultrasound assisted FNAC of the thyroidal gland, one of the three research needles will be used on the patient. When 112 patients per needle are included,336 in total, the endpoint of the study is reached. The question this study addresses is: can the diagnostic-result for a FNAC of the thyroidal gland be improved using a needle with a smaller diameter and/or a special coating? For statistical analyses the number of not-diagnostical and diagnostical results will be reported. In this study two proportions are compared, based on the normal approximation to the binomial distribution. The equation used for the sample size is: N = 2 . [Zcrit (2 pmean(1- pmean)) + Zpwr (p1(1- p1) + p2 (1- p2))]2 / D2 Is this equation the following values were used: p1 = 0.76 p2 = 0.90 pmean = 0.83 D = 0.14 Zcrit = 1.960 (significance criterion = 0.05) Zpwr = 0.842 (power = 0.80) The values p1 and p2 are the pre-study estimates based on the current diagnostical results by F. Pessers. His diagnostical percentage on the current needle is 76% and he tested one of the new needles with an outcome of 90%. In the study by F. Pessers (2012, January) the overall not-diagnostical percentage was 35,7%. The Zcrit and Zpwr are taken from table 1 and 2 in an article by Eng1. The outcome of this equation: N = 112 per needle. The two groups comprising N are equal in number, and two-tailed statistical analysis will be us	—

Measure

Time frame

The main study parameter is to achieve a higher percentage of diagnostical-results. This goal will be achieved when the percentage diagnostical-result will increase. Because of the low current percentage diagnostical-result comparing to the national percentage mentioned in literature, the investigators wish to achieve an increased percentage of 5%. In this case the new percentage diagnostical-results will be 81%, and the investigators will speak of clinical relevance. Off course the higher the outcome, the better it will be for the patients. During the ultrasound assisted FNAC of the thyroidal gland, one of the three research needles will be used on the patient. When 112 patients per needle are included,336 in total, the endpoint of the study is reached. The question this study addresses is: can the diagnostic-result for a FNAC of the thyroidal gland be improved using a needle with a smaller diameter and/or a special coating? For statistical analyses the number of *not-diagnostical* and *diagnostical* results will be reported. In this study two proportions are compared, based on the normal approximation to the binomial distribution. The equation used for the sample size is: N = 2 . [Zcrit *(2 pmean(1- pmean)) + Zpwr *(p1(1- p1) + p2 (1- p2))]2 / D2 Is this equation the following values were used: p1 = 0.76 p2 = 0.90 pmean = 0.83 D = 0.14 Zcrit = 1.960 (significance criterion = 0.05) Zpwr = 0.842 (power = 0.80) The values p1 and p2 are the pre-study estimates based on the current diagnostical results by F. Pessers. His diagnostical percentage on the current needle is 76% and he tested one of the new needles with an outcome of 90%. In the study by F. Pessers (2012, January) the overall not-diagnostical percentage was 35,7%. The Zcrit and Zpwr are taken from table 1 and 2 in an article by Eng1. The outcome of this equation: N = 112 per needle. The two groups comprising N are equal in number, and two-tailed statistical analysis will be us

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Secondary

Measure	Time frame
n.v.t.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)