Clinical trial NCT02307253: EUS GUIDED Transduodenal Biopsy Using the 19G Flex
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Neoplasms
Keywords: EUS-guided biopsy, EUS-FNB
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Intraoperative
Secondary outcomes:
measure: Number of Complications Divided Per Total Number of Enrolled Patients
timeFrame: intraoperative and within 3 days after the procedure
measure: Number of Histological Samples Judged Adequate Divided by the Total Number of Patients
timeFrame: 5 days
measure: Number of Correct Diagnosis Divided by the Total Number of Patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Univerisity Health Medical Center
state: Indiana
city: Paris
country: France
facility: Clinique du Trocadero
city: Bologna
country: Italy
facility: AUSL Bologna Bellaria-Maggiore Hospital
city: Palermo
country: Italy
facility: ISMETT UPMC Italy
city: Rome
country: Italy
facility: Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore
city: Kawasaki
country: Japan
facility: Teikyo University Mizonokuchi Hospital, Departement of Gastroenterology
state: Kanagawa
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Guido Costamagna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.