Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer
1 other identifier
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pancreatic-cancer
Started Jul 2013
Shorter than P25 for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedApril 27, 2016
April 1, 2016
1.6 years
June 4, 2013
April 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The presence of histologic core
Up to 1 year
Other Outcomes (1)
Procedure related complications
Up to 1 year
Study Arms (2)
22 gauge ProCore needle aspiration
ACTIVE COMPARATOREUS-guided pancreatic mass aspiration with 22 gauge ProCore needle
22 gauge Fine needle aspiration
ACTIVE COMPARATOREUS-guided pancreatic mass aspiration with 22 gauge Fine needle
Interventions
Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration
Pancreatic mass evaluation through the 22 gauge Fine needle aspiration
Eligibility Criteria
You may qualify if:
- Patients who agree to participate in research
- years of age and older patients less than 80 years old
- Patients who have suspected unresectable pancreatic cancer in imaging studies
You may not qualify if:
- Contraindication to endoscopy
- Patients younger than 18 years old or older than 80 years old
- Bleeding tendency
- Cardiopulmonary dysfunction
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Olympuscollaborator
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kwang Hyuck Lee, MD.
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 4, 2013
First Posted
June 12, 2013
Study Start
July 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
April 27, 2016
Record last verified: 2016-04