EUS GUIDED Transduodenal Biopsy Using the 19G Flex

Not Applicable

Completed

Conditions: Abdominal Neoplasms

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

Registration Number: NCT02307253

Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 246

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with solid lesions	Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)	Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)

Primary Outcome Measures

Name	Time	Method
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	Intraoperative	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.

Secondary Outcome Measures

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

Trial Locations

Locations (6): Indiana Univerisity Health Medical Center
🇺🇸
Indianapolis, Indiana, United States
AUSL Bologna Bellaria-Maggiore Hospital
🇮🇹
Bologna, Italy
Teikyo University Mizonokuchi Hospital, Departement of Gastroenterology
🇯🇵
Kawasaki, Kanagawa, Japan
ISMETT UPMC Italy
🇮🇹
Palermo, Italy
Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore
🇮🇹
Rome, Italy
Clinique du Trocadero
🇫🇷
Paris, France