Clinical trial NCT02909530: Comparison Between Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in EUS-guided FNB of Solid Pancreatic Masses
Official title: Comparison Between the Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in Endoscopic Ultrasound-guided Fine Needle Biopsy of Solid Pancreatic Masses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Keywords: Endoscopic ultrasound-guided fine needle biopsy
Olympus EZ Shot 3Plus
Olympus EZ Shot 2
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* solid pancreatic mass and consecutive indication for EUS-FNB

Exclusion Criteria:

* incapacity to give informed consent
* Haemorrhagic disease, disorder of hemostasis and coagulation (PT \<60%, PTT\> 42 sec. and platelets \<60000/µL)
* oral anticoagulants
* dual antiplatelet therapy with thienopyridines (e.g. clopidogrel)
* Pregnant or lactating

Primary outcomes:
measure: Correct histological diagnosis of the mass assessed by each needle
timeFrame: 6 months
Secondary outcomes:
measure: technical failure (inability to push the EUS-FNB needle out the endoscope to perform puncture)
timeFrame: Day one
measure: histological quality of the specimen retrieved (visual analog scale)
timeFrame: 24 months
measure: histological quality of the specimen retrieved (over all satisfaction)
timeFrame: 24 months
measure: Duration of procedure
timeFrame: Day one
measure: Adverse events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Israelitisches Krankenhaus Hamburg
city: Osnabrück
country: Germany
facility: Niel Stensen Kliniken Marienhospital Osnabrück
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart, Katharinenhospital
city: Ulm
country: Germany
facility: University Ulm
Study officials:
affiliation: University Ulm
name: Alexander Meining
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hann A, Epp S, Veits L, Rosien U, Siegel J, Moschler O, Bohle W, Meining A. Multicenter, randomized comparison of the diagnostic accuracy of 19-gauge stainless steel and nitinol-based needles for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic masses. United European Gastroenterol J. 2020 Apr;8(3):314-320. doi: 10.1177/2050640619887580. Epub 2019 Nov 7.