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

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909530
• Other study ID #: 222/16
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2019
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Israelitisches Krankenhaus Hamburg	Hamburg
Germany	Niel Stensen Kliniken Marienhospital Osnabrück	Osnabrück
Germany	Klinikum Stuttgart, Katharinenhospital	Stuttgart
Germany	University Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	histological quality of the specimen retrieved (visual analog scale)	Comparison of histological Quality using visual analog scale	24 months
Secondary	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
Secondary	Duration of procedure	time frame between Insertion and extraction of needle or failure to conduct FNB	Day one
Secondary	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