Primary objective: to obtain an comparison of the diagnostic result after an ultrasound assisted fine needle aspiration cytology (FNAC) of the thyroidal gland by use of a smaller diameter (25G) and / or a special coating.
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 used.
Two-tailed statistical analysis will be used because it is unknown whether or
not the new needles will have a better diagnostical outcome in comparison to
the currently used needle. The whole study population will be: 3x112=336.
Secondary outcome
n.v.t.
Background summary
To diagnose a thyroidal gland abnormality, at the Jeroen Bosch Hospital, an
ultrasound assisted fine needle aspiration cytology (FNAC) takes place. A
recent study by F. Pessers shows that the results of the fine needle aspiration
cytology in this hospital are lower in comparison to the literature. In
general, 8-20% of FNACs result in a *not-diagnostic* outcome. In this case the
Radiologist did not retrieve enough thyroidal cells for the laboratory to
diagnose the type of cells. The Jeroen Bosch Hospital has an outcome of 35,7%
non-diagnostic material. The study by F. Pessers showed that use of different
needles by different Radiologists result in a wide variety of non-diagnostic
results. The lowest score was a 100% not-diagnostic rate, the highest score was
a 0% not-diagnostic rate. Not every Radiologist performed the same amount of
FNACs (this varies between 1 and 30). The higher the number of biopsies, the
better the outcome.
The used needle diameters at the Jeroen Bosch Hospital varies between 18G
(Gauge) and 27G (Gauge). The investigator thinks the percentage of diagnostic
material can be improved by using a needle with a 25G diameter and/or by using
a needle with a special coating that improves the capillary action.
This study will compare two needles with a smaller diameter and/or special
coating to the currently used needle.
The power of the study should be at least 80% to get a statistic reliable
research, therefore at least 336 patients will be included. Statistical
significance will be assumed when the P value is < 0.05. Ninety-five percent
confidence intervals will be calculated for proportions based on exact binomial
tables. Statistical analysis will be performed with SPSS version 20.0 software
(SPSS, Chicago, IL, USA).
The patient population will be divided into three equal groups randomly.
- 1. Currently used needle A: BD Microlance 3, 22Gx50 mm
- 2. New needle B: Inrad 25Gx40 mm, anticoagulantia coating Procytin*
- 3. New needle C: B.Braun sterican 25Gx40 mm.
Study objective
Primary objective: to obtain an comparison of the diagnostic result after an
ultrasound assisted fine needle aspiration cytology (FNAC) of the thyroidal
gland by use of a smaller diameter (25G) and / or a special coating.
Study design
A interventional study design will be used for a comparison between three
needles used in FNAC of the thyroidal gland. 336 patients with thyroid nodi and
cysts will be included in the study. All patients who are redirected by the
specialist or general practitioner with abnormalities in the thyroidal gland
will be included in this study. Except patients who refuse to participate in
the study and patients who are younger than 18 years. These patients will be
informed about this study through a letter explaining the content of the study.
After giving their written informed consent, the patients described above, are
included in the study. The patients will undergo the FNAC of the thyroidal
gland the same way as patients who will not be a part of the study. The only
difference for the patient is the ad random selection of de needle which will
be used during the fine needle aspiration cytology. The need for a FNAC of the
thyroidal gland is decided by the treating doctor. However, if there are no
abnormalities seen during the ultrasound the Physician Assistant will not
perform a FNAC.
During the study the fine needle aspiration cytology of the thyroidal gland
will be executed by only the Physician Assistant. In case F. Pessers (PA) is
unable to execute the FNAC, an AIOS of the department of Radiology will execute
the FNAC. F. Pessers is allowed to perform FNAC of the thyroidal gland within
the Jeroen Bosch Ziekenhuis. This is not registered in the BIG-registration,
but F. Pessers has a GAIA accreditation. There is also a competence declaration
signed by a Radiologist which declares F. Pessers is allowed to perform FNAC of
the thyroidal gland within the Jeroen Bosch Ziekenhuis).
The three needles used in this study are the:
1. Currently used needle A: BD Microlance3, 22Gx50mm
2. New needle B: Inrad 25Gx40mm, anticoagulantia coating Procytin*
3. New needle C: B.Braun sterican 25Gx40 mm
The obtained material will be sent to the pathological anatomical laboratory
where it will be fixated and examined. If the results are *non-diagnostical*,
the examination has to be repeated. Non-diagnostical material in this study
means that the cytological material is insufficient either inadequate. Because
of this, the pathologist is not able to interpret this material. When there are
less than 6 groups of 10 cells each present, the cytological material is
considered to be insufficient. In this case, there are not enough cells
available for the pathologist to interpret. If the presence of one atypical
cell is determined, the cytological material is considered to be diagnostic.
One speaks of inadequate material when there are colloid cells present as well
as follicular cells and in case blood is dominantly present in the cytological
material. These are international guidelines, also know as the *Bethesda
criteria*.
There are currently 5 pathologists active at the Jeroen Bosch Hospital who
interpret the cytological material obtained by FNAC of the thyroid. They use
the same guidelines and review the material they receive the same way. At this
moment, there is no significant difference between the reviews of the 5
pathologists. The pathologists are not informed about the needle that is used
on each patient. So their review will not be influenced. Rotation of the
proceedings of each pathologist takes place. This way the average reviews of
each pathologist is considered to be equal. After examining 150 patients (about
30 patients (± 5 patients) per pathologist) an evaluation will take place if
the above is correct. If not, the laboratory will be informed and they will try
to adjust their rotation schedule for an equal amount of reviews. The final
result of the cytological outcome will be scored by the pathologist and
introduced into our hospitals lab-results-system called Mirador.
Intervention
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 used. This will be determined by
faith.
Study burden and risks
There are no risks involved. The examination will take about 30 minutes.
Compared to the current exam, the burden for the patient will be the same. In
case the first FNAC has a diagnostic outcome (vs. a non-diagnostic outcome),
the burden for the patient will decrease.
Henri Dunantstaat 1
's-Hertogenbosch 5223 GZ
NL
Henri Dunantstaat 1
's-Hertogenbosch 5223 GZ
NL
Listed location countries
Age
Inclusion criteria
Patients with a thyroid nodule on ultrasound
Age greater than 18
Ability to give written informed consent
Exclusion criteria
Patient refusal
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41615.028.12 |