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

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ClinicalTrials.gov Identifier: NCT02307253
Recruitment Status : Completed
First Posted : December 4, 2014
Results First Posted : June 27, 2022
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Guido Costamagna, Catholic University of the Sacred Heart

Study Description
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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.

Condition or disease Intervention/treatment Phase
Abdominal Neoplasms Device: Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : June 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. Number of Complications Divided Per Total Number of Enrolled Patients [ Time Frame: 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

  2. Number of Histological Samples Judged Adequate Divided by the Total Number of Patients [ Time Frame: 5 days ]
    percentage of patients in whom a histologically interpretable specimen will be retrieved

  3. Number of Correct Diagnosis Divided by the Total Number of Patients [ Time Frame: 6 months ]
    rate of correct diagnosis obtained through analysis of the tissue samples acquired with EUS fine needle biopsy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307253


Locations
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United States, Indiana
Indiana Univerisity Health Medical Center
Indianapolis, Indiana, United States, 46202
France
Clinique du Trocadero
Paris, France
Italy
AUSL Bologna Bellaria-Maggiore Hospital
Bologna, Italy, 40139
ISMETT UPMC Italy
Palermo, Italy, 90100
Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore
Rome, Italy, 00168
Japan
Teikyo University Mizonokuchi Hospital, Departement of Gastroenterology
Kawasaki, Kanagawa, Japan, 213-8507
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Guido Costamagna, MD Catholic University of the Sacred Heart
More Information
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Publications of Results:

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Responsible Party: Guido Costamagna, Professor of Surgery, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02307253    
Other Study ID Numbers: 7427/13
First Posted: December 4, 2014    Key Record Dates
Results First Posted: June 27, 2022
Last Update Posted: June 27, 2022
Last Verified: May 2022
Keywords provided by Guido Costamagna, Catholic University of the Sacred Heart:
EUS-guided biopsy, EUS-FNB
Additional relevant MeSH terms:
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Abdominal Neoplasms
Neoplasms by Site
Neoplasms