Trial Information

EMUNE-07 Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer

This is a prospective randomized controlled trial which will recruit patients referred for
suspicion of pancreatic mass and indication of EUS-FNA as part of standard of care in the
Interventional Endoscopy Unit at the University Of Chicago Medical Center. Basic demographic
data will be recorded for each patient. If a pancreatic mass is confirmed in EUS evaluation
the patient will be randomized in a 1:1 ratio to either Control group (Single needle) or
Investigational group (Multiple Needle). There will be an expert cytopathologist in the
exploration room (blinded to the group assignment). Samples obtained through FNA will be
prepared onsite either for cytological evaluation by the cytopathologist: each fine needle
sample will be expressed by using a 10mL air-filled syringe onto a separate glass slide, and
a direct smear will be made by an on-site cytopathologist. Each slide will be air-dried
and/or alcohol fixed (95% ethanol), and direct smears will be prepared for immediate
interpretation by staining with Diff-quick staining system.

Patients assigned to simple needle group (SN) will be sampled for a total of 6 consecutive
FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced
performance). After completing the 6th pass the endoscopist will be informed by the onsite
cytopathologist about the preliminary cytological diagnosis.

Patients assigned to multiple needle group (MN) will be sampled for a total of 6 consecutive
FNA passes, replacing the needle after every 2 passes. After completing the 6th pass the
endoscopist will be informed by the onsite cytopathologist about the preliminary cytological
diagnosis.

A cytopathologist (#1) will be present during each EUS-FNA procedure to prepare the slides
and determine whether each specimen was adequately cellular. After the procedure, all the
cytological samples will be sent to the Pathology department in order to complete the study.
A cytopathologist (#2) not present during the procedure will study all the sampling
specimens obtained during the EUS-FNA procedure and produce the final and definitive
cytopathological diagnosis.

Criteria for pancreatic cancer and benign pancreatic lesions will be defined. Follow-up of
all patients to assess early and late complications will be carried out for 30 days after
the procedure.

Endpoints:

1. Primary endpoint: Evaluate if the early change of needle during EUS-FNA for suspected
pancreatic cancer can reduce the number of passes needed to obtain a preliminary
cytological diagnosis of neoplasia. We hypothesized that the number of passes needed
using the multiple needles will be significantly less than that using the single
needle.

2. Secondary endpoints:

- Rate of complications related with EUS-FNA

- Influence of different factors in obtaining a positive cytological result
(histological differentiation)