EUS GUIDED Transduodenal Biopsy Using the 19G Flex

Catholic University of the Sacred Heart246 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

246

Conditions

Abdominal Neoplasms

Interventions

Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)DEVICE

EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (6)

Indiana Univerisity Health Medical Center

Indianapolis, Indiana, United States

Clinique du Trocadero

Paris, France

AUSL Bologna Bellaria-Maggiore Hospital

Bologna, Italy

ISMETT UPMC Italy

Palermo, Italy

Outcomes

Primary Outcomes

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.

Time frame: Intraoperative

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 6 months

Data from ClinicalTrials.gov

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