EUS GUIDED Transduodenal Biopsy Using the 19G Flex

Abdominal Neoplasms Clinical Trial

— NIFLEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307253
• Other study ID #: 7427/13
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: May 2022
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Clinique du Trocadero	Paris
Italy	AUSL Bologna Bellaria-Maggiore Hospital	Bologna
Italy	ISMETT UPMC Italy	Palermo
Italy	Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore	Rome
Japan	Teikyo University Mizonokuchi Hospital, Departement of Gastroenterology	Kawasaki	Kanagawa
United States	Indiana Univerisity Health Medical Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Countries where clinical trial is conducted

United States,  France,  Italy,  Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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