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Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Neoplasms

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Trial Information

Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study


Patient and methods:

Patients who have pancreatic or peripancreatic mass in imaging studies which need pathologic
confirm. These patients were randomly assigned to 22 gauge or 25 gauge group.

Procedure:

They underwent EUS-guided FNA, 3 times with 10 times of to-and pro movement each.

The number of patients required:

One hundred fifty five patients in each group The investigators assumed that the accuracy of
25 gauge is not inferior to 22 gauge, if the accuracy of 25 gauge is within the 10% of the
accuracy of 22 gauge. (under 5% significant level, 80% power)


Inclusion Criteria:



- Patients who agree to participate in research

- 18 years of age and older patients

- Patients who have pancreatic or peripancreatic mass in imaging studies

Exclusion Criteria:

- Contraindication to endoscopy

- Patients younger than 18 years old

- Bleeding tendency

- Cardiopulmonary dysfunction

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic accuracy

Outcome Description:

Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis

Outcome Time Frame:

October. 2014

Safety Issue:

No

Principal Investigator

Kwanghyuck Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center

Authority:

South Korea: Institutional Review Board

Study ID:

2012-08-066-001

NCT ID:

NCT01727921

Start Date:

January 2013

Completion Date:

November 2014

Related Keywords:

  • Pancreatic Neoplasms
  • ProCore FNA biopsy
  • Neoplasms
  • Pancreatic Neoplasms

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