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

NCT ID: NCT02909530

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-02-28

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.

Conditions

Pancreatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

First pass EZ Shot 3Plus then EZ Shot 2

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.

Group Type: ACTIVE_COMPARATOR

EUS-FNB with EZ Shot 3Plus first

Intervention Type: DEVICE

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.

First pass EZ Shot 2 then EZ Shot 3Plus

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.

Group Type: ACTIVE_COMPARATOR

EUS-FNB with EZ Shot 2 19G first

Intervention Type: DEVICE

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.

Interventions

EUS-FNB with EZ Shot 3Plus first

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.

Intervention Type: DEVICE

EUS-FNB with EZ Shot 2 19G first

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Alexander Meining

Prof. Dr. Alexander Meining

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Meining

Role: PRINCIPAL_INVESTIGATOR

University Ulm

Locations

Israelitisches Krankenhaus Hamburg

Hamburg, , Germany

Niel Stensen Kliniken Marienhospital Osnabrück

Osnabrück, , Germany

Klinikum Stuttgart, Katharinenhospital

Stuttgart, , Germany

University Ulm

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 32213013 (View on PubMed)

Other Identifiers

222/16

Identifier Type: -

Identifier Source: org_study_id