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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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

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Abdominal Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Adominal neoplasms patients

Patients in whom EUS-FNTA is performed with a novel type of biopsy neede.

Group Type EXPERIMENTAL

Fine Needle Tissue Acquisition

Intervention Type OTHER

diagnostic

Interventions

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Fine Needle Tissue Acquisition

diagnostic

Intervention Type OTHER

Other Intervention Names

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FNTA

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No