Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer

Samsung Medical Center

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Device: 22 gauge ProCore needle aspiration; Device: 22 gauge Fine needle aspiration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01876069

2013-02-018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

22 gauge ProCore needle aspiration

Active Comparator group

Description:

EUS-guided pancreatic mass aspiration with 22 gauge ProCore needle

Treatment:

Device: 22 gauge ProCore needle aspiration

22 gauge Fine needle aspiration

Active Comparator group

Description:

EUS-guided pancreatic mass aspiration with 22 gauge Fine needle

Treatment:

Device: 22 gauge Fine needle aspiration