EUS GUIDED Transduodenal Biopsy Using the 19G Flex

Study Overview
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Brief Summary
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This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the acquisition of samples for histologic analysis. Patients with lesions that can be approached only from the duodenum will be prospectively enrolled.

Detailed Description
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A 19 gauge needle in nitinol (Flex needle) has been recently become available for EUS guided procedure. The use of nitinol should guarantee a better needle flexibility with a theoretical advantage on the use of this needle for lesions that need to be sampled through the duodenum. Moreover, samples for histologic examination seems to be easy to interpret than cytologic ones allowing evaluate of the overall architecture of the tissue, better performance of immunohistochemical staining, and may be of additional value to perform tissue profiling that in the future will be very important to guide individualized therapies The existing data on the performance of the Flex needle for EUS-guided transduodenal biopsy are coming form a single study performed in one single center. Thus, the reproducibility of these results is unknown and multicenter prospective studies are warranted to answer this important question.

Official Title
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EUS-guided Fine Needle Tissue Acquisition Using a Newly Developed Nitinol Ultra Flex 19 Gauge Needle for Transduodenal Lesions: a Multicenter Prospective Feasibility Study

Conditions
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Abdominal Neoplasms

Intervention / Treatment
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* Device: Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. Age greater than 18 and less than 90. B. Presence of a solid lesion of the gastrointestinal tract adjacent to the duodenum with no previous tissue diagnosis. C. 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. D. Informed consent is obtained. Exclusion Criteria: A. 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. B. Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum. C. They are unable to understand and/or read the consent form.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with solid lesions<br>Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) | Device: Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)<br>* EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion | Number of patients in which it was possible to place the needle within the target lesion by a transduodenal route divided by the total number of enrolled patients. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Complications Divided Per Total Number of Enrolled Patients | 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 | intraoperative and within 3 days after the procedure | 
| Number of Histological Samples Judged Adequate Divided by the Total Number of Patients | percentage of patients in whom a histologically interpretable specimen will be retrieved | 5 days | 
| Number of Correct Diagnosis Divided by the Total Number of Patients | rate of correct diagnosis obtained through analysis of the tissue samples acquired with EUS fine needle biopsy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS-guided biopsy, EUS-FNB