Comparison Between Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in EUS-guided FNB of Solid Pancreatic Masses

Study Overview
=================
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.

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

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Device: EUS-FNB with EZ Shot 3Plus first
* Device: EUS-FNB with EZ Shot 2 19G first


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First pass EZ Shot 3Plus then EZ Shot 2<br>Olympus EZ Shot 3Plus will be used to puncture the mass first (Intervention EUS-FNB with EZ Shot 3Plus first), then the 19G and EZ Shot 2 will be used to puncture the pancreatic mass. | Device: EUS-FNB with EZ Shot 3Plus first<br>* Both needles (EZ Shot 3Plus 19G and EZ Shot 2 19G) will be used for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) in each patient following a predetermined random order which needle is used to pass through the tumor first.<br>|
| Active Comparator: First pass EZ Shot 2 then EZ Shot 3Plus<br>Olympus EZ Shot 2 will be used to puncture the mass first (Intervention EUS-FNB with EZ Shot 2 19G first), then the EZ Shot 3Plus will be used to puncture the pancreatic mass. | Device: EUS-FNB with EZ Shot 2 19G first<br>* Both needles (EZ Shot 3Plus 19G and EZ Shot 2 19G) will be used for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) in each patient following a predetermined random order which needle is used to pass through the tumor first.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct histological diagnosis of the mass assessed by each needle | Correct histological diagnosis of the mass assessed by each needle compared to gold standard. Gold standard is primarily positive histology, followed by diagnosis made due to additional methods to assess for malignancy (ultrasound, CT, ERCP, surgically retrieved specimen). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical failure (inability to push the EUS-FNB needle out the endoscope to perform puncture) | Number of failure to push the needle out of the endoscope to perform biopsy counted per needle type. | Day one | 
| histological quality of the specimen retrieved (visual analog scale) | Comparison of histological Quality using visual analog scale | 24 months | 
| histological quality of the specimen retrieved (over all satisfaction) | Comparison of histological Quality using over all satisfaction (1<2, 1=2, 1>2) | 24 months | 
| Duration of procedure | time frame between Insertion and extraction of needle or failure to conduct FNB | Day one | 
| Adverse events | Acquisition of immediate adverse events related to the procedure or adverse events in the following 24 hours surveillance period or reported delayed adverse events (over 24 hours) related to the procedure | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic ultrasound-guided fine needle biopsy, Olympus EZ Shot 3Plus, Olympus EZ Shot 2