NCT04032951

22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination

Evaluation of a Newly Designed 22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination in Patients With Solid Lesions: A Prospective Two Centers Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 10 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To determine the yield of tissue biopsy specimen and the diagnostic accuracy of tissue acquisition using a newly developed 22 gauge needle in patients with solid lesions throughout the GI tract.

Detailed description

The use of 22 gauge needle to gather tissue samples under EUS guidance has not been associated with an increased risk, and no major complications have been described so far both for the 22 gauge Procore needle and for standard 22 gauge.20, 21 Potential benefits of this new needle are the possibility of increasing the chance of retrieving tissue specimens for histological examination, with the possibility of increasing the diagnostic accuracy of the procedure saving the need and the cost deriving from on-site cytopathology examination. This may reduce the need to repeat EUS procedures or other more invasive sampling procedures, including surgery.

Conditions

• Abdominal Neoplasms

Interventions

Type	Name	Description
OTHER	Fine Needle Tissue Acquisition	diagnostic

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2019-07-25
• Last updated: 2019-07-25

Locations

2 sites across 1 country: Italy