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

Abdominal Neoplasms Clinical Trial

— EUSFNTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032951
• Other study ID #: 10012/14
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: July 2019
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age greater than 18 and less than 80.

• Presence of a solid lesion within or adjacent of the gastrointestinal tract. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.

• Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.

• Informed consent is obtained

Exclusion Criteria:

• Previous biopsy of the lesion with diagnosis of malignancy

• Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.

• They are unable to understand and/or read the consent form.

Related Conditions & MeSH terms

• Abdominal Neoplasms

Intervention

Other:
• Fine Needle Tissue Acquisition
diagnostic

Locations

Country	Name	City	State
Italy	ISMETT	Palermo
Italy	Universita cattolica del sacro cuore	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA.	diagnostic accuracy	intraoperative
Secondary	rate of complications	- The rate of complications, divided in procedural complication (perforation, bleeding) occurring during the procedure and late complications (delayed bleeding, infection) occurring during the post-procedural observational period.	perioperative