EUS GUIDED Transduodenal Biopsy Using the 19G Flex (NIFLEX)

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Neoplasms
• Intervention / Treatment: Device: Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)

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.

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Clinique du Trocadero
• Italy
  • Bologna, Italy, 40139
    • AUSL Bologna Bellaria-Maggiore Hospital
  • Palermo, Italy, 90100
    • ISMETT UPMC Italy
  • Rome, Italy, 00168
    • Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore
• Japan
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 213-8507
      • Teikyo University Mizonokuchi Hospital, Departement of Gastroenterology
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Univerisity Health Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Investigators: Principal Investigator: Guido Costamagna, MD, Catholic University of the Sacred Heart

Publications and helpful links

General Publications

• Varadarajulu S, Bang JY, Hebert-Magee S. Assessment of the technical performance of the flexible 19-gauge EUS-FNA needle. Gastrointest Endosc. 2012 Aug;76(2):336-43. doi: 10.1016/j.gie.2012.04.455.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 19, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: EUS-guided biopsy, EUS-FNB
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms
• Other Study ID Numbers: 7427/13