Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01876069|
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : April 27, 2016
Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate diagnosis of a pancreatic mass is important to direct patient management. Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To overcome these limitations, a new needle device with ProCore reverse-bevel technology was developed recently.
The objective of this prospective study is to compare the rate of diagnostic sufficiency in the EUS sampling by using newly developed ProCore needle with conventional FNA needle in suspected unresectable pancreatic cancer. We will also compare the safety, the yield of histologic core tissue and the cost-effectiveness between these modalities.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Device: 22 gauge ProCore needle aspiration Device: 22 gauge Fine needle aspiration||Not Applicable|
Newly diagnosed pancreatic cancer patient whose cancer lesion is suspected unresectable in diagnostic imaging such as CT or MRI
Each EUS-guided FNA and ProCore aspiration will performed twice in same patient. The priority of order will be given by randomization assignment.
The number of patients required:
Total sixty five patients will be required.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Endoscopic Ultrasonography-guided Sampling of Suspected Unresectable Pancreatic Cancer|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Active Comparator: 22 gauge ProCore needle aspiration
EUS-guided pancreatic mass aspiration with 22 gauge ProCore needle
Device: 22 gauge ProCore needle aspiration
Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration
Other Name: EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
Active Comparator: 22 gauge Fine needle aspiration
EUS-guided pancreatic mass aspiration with 22 gauge Fine needle
Device: 22 gauge Fine needle aspiration
Pancreatic mass evaluation through the 22 gauge Fine needle aspiration
Other Name: 22 gauge, EN-SHOT2 Side Port Aspiration Needle
- The rates of diagnostic sufficiency [ Time Frame: Up to 1 year ]The rates of diagnostic sufficency will be assessed by the pathologist as the proportion of definate diagnosis from cytology and histology within 2 passes of each procendure
- The presence of histologic core [ Time Frame: Up to 1 year ]The presence histologic core means the gain of tissue, not clustered cells, through each procedure. It will be also assessed by the pathologist.
- Procedure related complications [ Time Frame: Up to 1 year ]Investigate the occurrence of complications such as bleeding, perforation, pancreatitis, infection. Not only complications, but the size and location of lesion, puncture routes will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876069
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Kwang Hyuck Lee, MD.||Samsung Medical Center|