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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876069
• Other study ID #: 2013-02-018
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: April 25, 2016
• Start date: July 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• 22 gauge ProCore needle aspiration
Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration
• 22 gauge Fine needle aspiration
Pancreatic mass evaluation through the 22 gauge Fine needle aspiration

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Olympus

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	No
Secondary	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	No