Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: 22 gauge ProCore needle aspiration Type: Device
Name: 22 gauge Fine needle aspiration Type: Device
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Kwang Hyuck Lee, MD. - 82-2-3410-1628 - kwanghyuck.lee@samsung.com
Start Date
June 2013
Completion Date
April 2014
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page