Clinical trialNACompleted
Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer
Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Endoscopic Ultrasonography-guided Sampling of Suspected Unresectable Pancreatic Cancer
- Outcome
- Finished, no results posted
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- July 2013
- Expected end
- February 2015
- Enrollment
- 65 participants
- Sites
- 1
- Primary outcomes
- The rates of diagnostic sufficiency
- Sponsor
- Other
- Results posted
- No
- Last update
- 27 April 2016
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Brief summary public domain (ClinicalTrials.gov)
Background: 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. Aims: 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.
Detailed description public domain (ClinicalTrials.gov)
Patient: Newly diagnosed pancreatic cancer patient whose cancer lesion is suspected unresectable in diagnostic imaging such as CT or MRI Procedure: 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.