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

Not Applicable

Completed

• Conditions: Pancreatic Cancer
• Interventions: Device: 22 gauge ProCore needle aspiration; Device: 22 gauge Fine needle aspiration

• Registration Number: NCT01876069
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-08
• Study First Posted: 2013-06-12
• Study Start: 2013-07
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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Exclusion Criteria

• Contraindication to endoscopy
• Patients younger than 18 years old or older than 80 years old
• Bleeding tendency
• Cardiopulmonary dysfunction
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
22 gauge ProCore needle aspiration	22 gauge ProCore needle aspiration	EUS-guided pancreatic mass aspiration with 22 gauge ProCore needle
22 gauge Fine needle aspiration	22 gauge Fine needle aspiration	EUS-guided pancreatic mass aspiration with 22 gauge Fine needle

Primary Outcome Measures

Name	Time	Method
The rates of diagnostic sufficiency	Up to 1 year	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

Secondary Outcome Measures

Name	Time	Method
The presence of histologic core	Up to 1 year	The presence histologic core means the gain of tissue, not clustered cells, through each procedure. It will be also assessed by the pathologist.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of