COMPARATIVE STUDY OF DIAGNOSTIC VALUE FOR THE ECHOTIP® PROCORE™ 22 Gauge NEEDLE VERSUS ECHOTIP® 22 Gauge IN THE DIAGNOSIS OF PANCREATIC SOLID TUMORS UNDER ENDOSCOPIC ULTRASONOGRAPHY : THE "PICORE" STUDY
18 Years
N/A
Both
Pancreatic Tumor, Fine Needle Aspiration, Endoscopic Ultrasonography
Trial Information
COMPARATIVE STUDY OF DIAGNOSTIC VALUE FOR THE ECHOTIP® PROCORE™ 22 Gauge NEEDLE VERSUS ECHOTIP® 22 Gauge IN THE DIAGNOSIS OF PANCREATIC SOLID TUMORS UNDER ENDOSCOPIC ULTRASONOGRAPHY : THE "PICORE" STUDY
Inclusion Criteria:
- Solid tumor of the pancreas (<50% share or anechoic fluid) to receive a biopsy under
endoscopic ultrasonography (EUS)
Exclusion Criteria:
- Contraindications to the achievement of an upper gastrointestinal endoscopy
- Haemorrhagic disease, disorder of hemostasis and coagulation (PT <60%, CaT> 40 sec.
and platelets <60000/mm3)
- Pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on
imaging)
- Pregnant or lactating
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Outcome Measure:
Diagnostic accuracy of fine needle aspiration Echo Tip® HD ProCore™ versus EchoTip® in the etiological cyto histological in pancreatic solid tumors explored under endoscopy ultrasonography.
Outcome Time Frame:
6 months
Safety Issue:
No
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2011-A00578-33
NCT ID:
NCT01479803
Start Date:
October 2011
Completion Date:
September 2012
Related Keywords:
- Pancreatic Tumor
- Fine Needle Aspiration
- Endoscopic Ultrasonography
- Pancreatic Neoplasms
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