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Trial record 16 of 130 for:    Pancreatic Cancer | ( Map: South Korea )

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

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ClinicalTrials.gov Identifier: NCT01876069
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
Olympus
Information provided by (Responsible Party):
Kwang Hyuck Lee, 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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: 22 gauge ProCore needle aspiration Device: 22 gauge Fine needle aspiration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Endoscopic Ultrasonography-guided Sampling of Suspected Unresectable Pancreatic Cancer
Study Start Date : July 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

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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 Name: 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 Name: 22 gauge, EN-SHOT2 Side Port Aspiration Needle




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876069


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Olympus
Investigators
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Principal Investigator: Kwang Hyuck Lee, MD. Samsung Medical Center

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Responsible Party: Kwang Hyuck Lee, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01876069     History of Changes
Other Study ID Numbers: 2013-02-018
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases