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

Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Endoscopic Ultrasonography-guided Sampling of Suspected Unresectable Pancreatic Cancer

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Device: 22 gauge ProCore needle aspiration; Device: 22 gauge Fine needle aspiration

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 22 gauge ProCore needle aspiration; EUS-guided pancreatic mass aspiration with 22 gauge ProCore needle	Device: 22 gauge ProCore needle aspiration; Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration; Other Names: EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
Active Comparator: 22 gauge Fine needle aspiration; EUS-guided pancreatic mass aspiration with 22 gauge Fine needle	Device: 22 gauge Fine needle aspiration; Pancreatic mass evaluation through the 22 gauge Fine needle aspiration; Other Names: 22 gauge, EN-SHOT2 Side Port Aspiration Needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Olympus
• Investigators: Principal Investigator: Kwang Hyuck Lee, MD., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: June 4, 2013
• First Submitted That Met QC Criteria: June 8, 2013
• First Posted (Estimate): June 12, 2013

Study Record Updates

• Last Update Posted (Estimate): April 27, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 2013-02-018