Clinical Trial: EUS GUIDED Transduodenal Biopsy Using the 19G Flex

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Catholic University of the Sacred Heart

Current Primary Outcome: 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. [ Time Frame: Intraoperative ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: Catholic University of the Sacred Heart

Dates:
Date Received: November 19, 2014
Date Started: June 2013
Date Completion: August 2015
Last Updated: December 1, 2014
Last Verified: November 2014