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

NCT ID: NCT01876069

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-02-28

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

22 gauge ProCore needle aspiration

EUS-guided pancreatic mass aspiration with 22 gauge ProCore needle

Group Type: ACTIVE_COMPARATOR

22 gauge ProCore needle aspiration

Intervention Type: DEVICE

Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration

22 gauge Fine needle aspiration

EUS-guided pancreatic mass aspiration with 22 gauge Fine needle

Group Type: ACTIVE_COMPARATOR

22 gauge Fine needle aspiration

Intervention Type: DEVICE

Pancreatic mass evaluation through the 22 gauge Fine needle aspiration

Interventions

22 gauge ProCore needle aspiration

Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration

Intervention Type: DEVICE

22 gauge Fine needle aspiration

Pancreatic mass evaluation through the 22 gauge Fine needle aspiration

Intervention Type: DEVICE

Other Intervention Names

EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle; 22 gauge, EN-SHOT2 Side Port Aspiration Needle

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Olympus

INDUSTRY

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kwang Hyuck Lee

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kwang Hyuck Lee, MD.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2013-02-018

Identifier Type: -

Identifier Source: org_study_id