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

Study Overview

Comparing Newly Developed PreCore Needle With Conventional Fine Needle in 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.

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.

Pancreatic Cancer

DEVICE: 22 gauge ProCore needle aspiration
DEVICE: 22 gauge Fine needle aspiration

2013-02-018

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-06-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-04-25
First Submitted that Met QC Criteria 2013-06-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-04-27
First Posted (ESTIMATED) 2013-06-12	Results First Posted N/A	Last Verified 2016-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Randomized

Interventional Model:
Single Group

Masking:
None

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
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

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

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Olympus

Investigators

PRINCIPAL_INVESTIGATOR: Kwang Hyuck Lee, MD., Samsung Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record