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Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle


N/A
18 Years
90 Years
Open (Enrolling)
Both
Pancreatic Mass, Abnormal Lymph Nodes, Mediastinal Masses, Gastric Submucosal Masses

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Trial Information

Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle


Inclusion Criteria:



- 3.1.1 All patients referred for EUS tissue sampling who provide informed consent

Exclusion Criteria:

- 3.2.1 Coagulopathy which is not corrected

3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic Yield of EUS-FNB

Outcome Description:

The investigators' primary outcome measure will assess the diagnostic yield (%) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Srinadh Komanduri

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

FNAFNBmucin

NCT ID:

NCT01769248

Start Date:

September 2012

Completion Date:

September 2013

Related Keywords:

  • Pancreatic Mass
  • Abnormal Lymph Nodes
  • Mediastinal Masses
  • Gastric Submucosal Masses
  • EUS
  • FNA
  • FNB
  • Marfan Syndrome

Name

Location
UCLA Medical Center Los Angeles, California  90095-7059
California Pacific Medical Center San Francisco, California  94115
Moffit Cancer Center Tampa, Florida  33612