Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is a valid and recommended
technique for tissue diagnosis of pancreatic masses. However, the diagnostic yield is with a
sensitivity of 64%-95% and an accuracy of 78%-94% still very low. The EUS-FNB of pancreatic
masses is usually performed with a 22-gauge biopsy needle. The small diameter of the needle
is usually responsible for the low yield of tissue samples for histopathological examination.
The 19-gauge needles help to overcome the limitations of a 22-gauge needle by acquiring a
larger amount of cellular material. Thus, performing EUS-FNB with a 19-gauge needle can
maximize tissue acquisition and sample adequacy, which is important for appropriate
diagnosis. Contrariwise, the technical success rate for sample retrieval in patients with
pancreatic head lesions is significantly lower using the 19-gauge compared to the 22-gauge
needle. This is attributable to the technical difficulty to push the needle out of the
endoscope in the duodenum. Since about 60% of pancreatic cancers are located in the head
region, it is therefore particularly important to improve technical success in these cases.
The new 19-gauge biopsy needle "Olympus EZ Shot3 Plus" is more flexible than common biopsy
needles such as "EZ Shot2" and should therefore provide improved access to regions like
pancreatic head. The aim of this multicenter prospective randomized crossover study is to
compare those two needles during EUS-FNB of solid pancreatic masses.
Therefore this study will enroll 40 patients in five German centers with solid pancreatic
masses and consecutive indication for EUS-FNB. Both needles will be used in each patient
following a predetermined random order.
Primary endpoint is the correct histological diagnosis of the mass assessed by each needle.
Technical failure is regarded as a negative histological diagnosis.
Secondary endpoints include a comparison of technical failure using each needle, histological
quality, duration of procedure and rate of adverse events.