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Completed

NCT Number: NCT01876069

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

22 gauge ProCore needle aspiration

Device

Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration

Other names: EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle

22 gauge Fine needle aspiration

Device

Pancreatic mass evaluation through the 22 gauge Fine needle aspiration

Other names: 22 gauge, EN-SHOT2 Side Port Aspiration Needle

Primary outcomes

  1. The rates of diagnostic sufficiency

    Time frame: 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 outcomes

  1. The presence of histologic core

    Time frame: 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.

Other outcomes

  1. Procedure related complications

    Time frame: Up to 1 year

    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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Olympus

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2013
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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