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| Name | Class |
|---|---|
| Olympus | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 22 gauge ProCore needle aspiration | Active Comparator | EUS-guided pancreatic mass aspiration with 22 gauge ProCore needle |
|
| 22 gauge Fine needle aspiration | Active Comparator | EUS-guided pancreatic mass aspiration with 22 gauge Fine needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 22 gauge ProCore needle aspiration | Device | Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rates of diagnostic sufficiency | 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 | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The presence of histologic core | The presence histologic core means the gain of tissue, not clustered cells, through each procedure. It will be also assessed by the pathologist. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure related complications | 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. | Up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwang Hyuck Lee, MD. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| 22 gauge Fine needle aspiration | Device | Pancreatic mass evaluation through the 22 gauge Fine needle aspiration |
|
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |