Trial Information

A Prospective, Single Blinded, Randomized, Controlled Study to Compare the Yield of Endoscopic Ultrasound Guided Fine Needle Aspiration (EUS-FNA) With and Without the Use of a Stylet in the Biopsy Needle

Research Method:

All patients referred for EUS who are also likely to require FNA will be screened for study
eligibility by way of the inclusion and exclusion criteria. After informed consent has been
obtained patients will be randomized to 2 different groups by random number generation

1. Stylet in FNA first, Stylet out FNA second

2. Stylet out FNA first, Stylet in FNA second As each method of tissue sampling will be
used for all patients they will effectively act as their own controls.

In patients randomized to the first group the stylet in is left in place within the needle
for the first three passes of the needle into the area to be sampled. A new 22 gauge EUS FNA
is then used to obtain the FNA with the stylet out.

In patients randomized to the second group a 22 gauge EUS FNA needle with the stylet out is
used for the first three passes. A new needle with the stylet in is subsequently used for
further sampling. Three passes will be done for each FNA biopsy.

For each patient the sample adequacy, the number of bloody passes and the number of passes
required to obtain an adequate sample will be recorded by the cytopathology technician. Each
tissue sample will be prepared and analysed by experienced on-site cytopathology staff, who
will be blinded to the group allocation of the respective patients. A positive or negative
diagnosis will be recorded when the final cytology result is available. At the end of the
study period a comparison between the two groups will be made in relation to the parameters
outlined above.

Statistical Analysis:

Endpoints:

The primary endpoint of our study will be the number of samples with a positive diagnosis in
each group. Secondary end-points will be the number of bloody passes, the sample adequacy
and the number of passes needed to obtain an adequate sample.

Sample size calculation:

The outcome will be represented as a proportion of FNA samples that have a positive
diagnosis. The effect size between the stylet in FNA and stylet out FNA is expected to be
30%. This is at a significance level of p= 0.05 and 80% power. The number of patients in
each arm is therefore 36.

Description of methodology All patients who are referred for a pancreatic EUS and are likely
to require an FNA will be identified and screened for eligibility for entry into the study
according to the inclusion and exclusion criteria. Those patients who are seen in the office
prior to an EUS appointment will be invited to enter the study by a research nurse or
research assistant not involved with the procedure. They will be provided with written and
verbal information on the study prior to making their decision. For patients who are
referred directly for an EUS-FNA from another physician and who are not seen in the office
beforehand a written invitation to enter the study will be sent in advance. This will
provide detailed information on the research proposal as well as a helpline number which
patients can use to contact one of the study co-ordinators for further advice. A follow up
phone call to patients will be made by a study co-ordinator before they attend for the EUS;
the initial contact letter will outline when this call will be made, and by whom.

If patients elect to enter into the study informed consent will be obtained prior to
randomization.

Summary of procedures In patients randomized to the first group, under intravenous sedation,
a linear endoscopic ultrasound examination is performed. The pancreatic mass is identified
by endoscopic ultrasound and using a 22 gauge EUS FNA needle with the stylet in is used for
the first pass. The stylet is then withdrawn and 10cc of suction is applied to the FNA
needle. A sample is obtained by moving the needle in and out of the lesion for a minimum of
15 times. The sample is then collected for cytopathology. The stylet is replaced in the
needle and another pass is performed by the same technique. Three passes will be done for
each FNA biopsy. A new 22 gauge EUS FNA is then used to obtain the FNA with the stylet out
by the same technique as outlined above.

In patients randomized to the second group, under intravenous sedation a linear endoscopic
ultrasound examination is performed. The pancreatic mass is identified by endoscopic
ultrasound and using a 22 gauge EUS FNA needle with the stylet out is used for the first
pass. The stylet is then withdrawn and 10cc of suction is applied to the FNA needle. A
sample is obtained by moving the needle in and out of the lesion for a minimum of 15 times.
The sample is then collected for cytopathology. The stylet is replaced in the needle and
once loaded into position, the stylet is removed prior to starting another pass performed by
the same technique. Three passes will be done for each FNA biopsy.

Adverse events that can potentially occur include oversedation (1:500), pancreatitis
(1:1000), perforation (1:5000), and bleeding (extremely rare with only one reported case in
press) For each patient the sample adequacy, the number of bloody passes and the number of
passes required to obtain an adequate sample will be recorded by the cytopathology
technician. Each tissue sample will be prepared and analysed by experienced on-site
cytopathology staff, who will be blinded to the group allocation of the respective patients.
A positive or negative diagnosis will be recorded when the final cytology result is
available. At the end of the study period a comparison between the two groups will be made
in relation to the parameters outlined above.

Follow-up:

Within one day, all patients will be contacted to determine if any adverse events have
occurred.