Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Endoscopic Ultrasonography-guided Sampling of Suspected Unresectable Pancreatic Cancer
18 Years
80 Years
Both
Pancreatic Cancer
Trial Information
Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Endoscopic Ultrasonography-guided Sampling of Suspected Unresectable Pancreatic Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
The rates of diagnostic sufficiency
Outcome Description:
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
Outcome Time Frame:
Up to 1 year
Safety Issue:
No
Principal Investigator
Kwang Hyuck Lee, MD.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Samsung Medical Center
Authority:
Korea: Institutional Review Board
Study ID:
2013-02-018
NCT ID:
NCT01876069
Start Date:
June 2013
Completion Date:
April 2014
Related Keywords:
- Pancreatic Cancer
- Pancreatic Neoplasms
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