Neoplasms

All Conditions

Abdominal Neoplasms

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

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

Guido Costamagna, MD

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.

EUS GUIDED Transduodenal Biopsy Using the 19G Flex

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

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.

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

percentage of patients in whom a histologically interpretable specimen will be retrieved

rate of correct diagnosis obtained through analysis of the tissue samples acquired with EUS fine needle biopsy

Catholic University of the Sacred Heart

Professor of Surgery

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

Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle

Patients With Solid Lesions

all consecutive patients with solid lesions who needed to undergo EUS for tissue sampling that had to be performed through the duodenum, such as for deep head/uncinate pancreatic masses, periduodenal lymph nodes, duodenal subepithelial lesions, aortocaval nodes, hilar tumors, right-sided liver lesions, right kidney lesions, right adrenal gland lesions, or periduodenal abdominal masses, were enrolled in the present study.

Selection criteria All adults (\>18 years of age) referred for EUS-FNA of solid lesions adjacent to or located in the wall of the duodenum with no previous tissue diagnosis were considered eligible. In the presence of a cystic component, the solid part of the lesion should have been more than 75% of the total. Patients with uncorrectable coagulopathy as defined by abnormal prothrombin time or partial thromboplastin time that did not normalize after administration of fresh frozen plasma, with altered anatomy of the upper GI tract due to surgery of the esophagus, stomach, and duodenum and those unable to understand and/or read the consent form were excluded from the current study.

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Japan

Italy

France

Region of Enrollment

Dr Alberto Larghi

Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle

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

Spots Global Cancer Trial Database for expect™19flex needle (boston scientific corp.,natick,ma,usa)