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2016-09
2018-02
2018-02
46
NCT02909530
University of Ulm
University of Ulm
INTERVENTIONAL
Comparison Between Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in EUS-guided FNB of Solid Pancreatic Masses
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 ȮZ 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-09-07 | N/A | 2019-02-19 |
2016-09-20 | N/A | 2019-02-22 |
2016-09-21 | N/A | 2019-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Crossover
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: 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. | DEVICE: EUS-FNB with EZ Shot 3Plus first
|
| ACTIVE_COMPARATOR: 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. | DEVICE: EUS-FNB with EZ Shot 2 19G first
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
