EUS-FNA With and Without Suction

Solid Pancreatic Mass Lesions Clinical Trial

Official title:

Randomized Single Blind Controlled Trial of EUS-FNA With and Without Suction for Adequate Cellblock Sample Procurement of Solid Pancreatic Mass Lesions Using 25G Needle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072915
• Other study ID #: F131108005
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: November 7, 2014
• Start date: January 2014
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To compare the number of passes required for cellblock acquisition with and without suction using the 25g needle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• All patients referred to UAB Endoscopy Unit for assessment of pancreatic mass lesions that requires FNA.

Exclusion Criteria:

• Age < 19 years

• Unable to safely undergo EUS for any reason

• Coagulopathy (INR>1.6, Prothrombin Time>18 secs, Thrombocytopenia < 80,000 cells/ml)

• Unable to consent

• Non-English speaking patients

Study Design

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

Related Conditions & MeSH terms

• Solid Pancreatic Mass Lesions

Intervention

Procedure:
• Suction

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of passes		once at baseline	No