Interest of Procore Needle® for Diagnosis of Lung Cancer

Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931461
• Other study ID #: PR-EBUS
• Status: Completed
• Phase: N/A
• Start date: October 27, 2016
• Est. completion date: July 16, 2018

Study information

• Verified date: May 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus standard 22 gauge needle for diagnosis of lung cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 16, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• mediastinal lymphadenopathy >10 millimeters

• lung cancer suspected

Exclusion Criteria:

• coagulopathy contraindication for midazolam contraindication for bronchoscopy

Related Conditions & MeSH terms

• Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore
• Lung Neoplasms

Intervention

Procedure:
• Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of histological diagnoses for each needle		6 months