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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- - Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater than 18 and less than
- •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.
Arms & Interventions
Adominal neoplasms patients
Patients in whom EUS-FNTA is performed with a novel type of biopsy neede.
Intervention: Fine Needle Tissue Acquisition (Other)
Outcomes
Primary Outcomes
- Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA.
Time Frame: intraoperative
diagnostic accuracy
Secondary Outcomes
- rate of complications(perioperative)
Investigators
Guido Costamagna
professor
Catholic University of the Sacred Heart