Pancreatic Cancer
Conditions
Brief summary
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
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.
Interventions
DEVICE22 gauge ProCore needle aspiration
Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration
DEVICE22 gauge Fine needle aspiration
Pancreatic mass evaluation through the 22 gauge Fine needle aspiration
Sponsors
Olympus
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who agree to participate in research * 18 years of age and older patients less than 80 years old * Patients who have suspected unresectable pancreatic cancer in imaging studies
Exclusion criteria
* Contraindication to endoscopy * Patients younger than 18 years old or older than 80 years old * Bleeding tendency * Cardiopulmonary dysfunction * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rates of diagnostic sufficiency | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The presence of histologic core | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedure related complications | 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. |
Countries
South Korea
Outcome results
None listed