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Completed

NCT Number: NCT02307253

EUS GUIDED Transduodenal Biopsy Using the 19G Flex

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique du Trocadero, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study 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

Acronym: NIFLEX

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2014
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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