EUS-FNA of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique

Pancreatic Neoplasm Clinical Trial

— EUS-FNA  

Official title:

Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111368
• Other study ID #: 41620315.9.0000.0068
• Status: Completed
• Phase: N/A
• First received: April 1, 2016
• Last updated: April 11, 2017
• Start date: April 27, 2015
• Est. completion date: June 23, 2016

Study information

• Verified date: June 2016
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

50 patients with pancreatic mass will undergo endoscopic ultrasound-guided fine needle aspiration using two techniques: negative pressure and slow-pull. Cytological results will be compared.

Description:

The study will analyze the cytological results of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic mass using two different techniques of needle suction. Negative pressure and slow-pull. 50 patients with pancreatic mass will be submitted to four passes with both techniques. Each patient will be randomized to decide which technique will be first and subsequently on a alternated fashion until four passes are completed. Smear cytology and cell block preparations for each technique were obtained. The pathologist was blinded for the EUS-FNA technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 23, 2016
• Est. primary completion date: June 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pancreatic solid mass

Exclusion Criteria:

• endoscopic ultrasound non accessible lesions

Related Conditions & MeSH terms

• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

Procedure:
• Endoscopic ultrasound-guided fine needle aspiration
pancreatic solid mass punctured with a 22G endoscopic ultrasound needle

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da FMUSP	Sao Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Boston Scientific Corporation, Medi - Globe

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	cytological results after endoscopic ultrasound fine needle aspiration	24 months