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

Not Applicable

Completed

• Conditions: Abdominal Neoplasms
• Interventions: Other: Fine Needle Tissue Acquisition

• Registration Number: NCT04032951
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-01-19
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-24
• Last Update Submitted: 2019-07-24
• Study First Posted: 2019-07-25
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adominal neoplasms patients	Fine Needle Tissue Acquisition	Patients in whom EUS-FNTA is performed with a novel type of biopsy neede.

Primary Outcome Measures

Name	Time	Method
- Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA.	intraoperative	diagnostic accuracy

Secondary Outcome Measures

Name	Time	Method
rate of complications	perioperative	- 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.

Trial Locations

Locations (2)

ISMETT; 🇮🇹 Palermo, Italy

Universita cattolica del sacro cuore; 🇮🇹 Rome, Italy