SharkCore Versus Acquire FNB

NCT03672032 | Completed Results FDA Device

• 1 other identifier: 201808820
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has been established as an effective technique for sampling tissue inside and around the gastrointestinal tract, including the pancreas, liver, lymph nodes, and adrenal glands. EUS-FNA is convenient, minimally invasive, and safe procedure with an estimated sensitivity of 75%-92% and a specificity of 82%-100%. Diagnosis of various pathologies in the GI tract including solid pancreatic masses, mediastinal or gastric lymph nodes, gastrointestinal submucosal lesions, and peri-rectal lesions require adequate tissue architecture and immunohistochemical analysis. This is difficult to obtain and is frequently insufficient with EUS-FNA cytology alone. The core tissue is required to improve the diagnostic yield and obtain histologic diagnosis along with immunostaining to establish specimen adequacy. In past 1 year two new needle EUS needle (Shark Core)and Acquire EUS needles has been introduced to improve diagnostic accuracy, tissue yield, and potentially obtain a core tissue sample. So far, no prospective studies have compared these two needles to see which one is better for overall diagnostic accuracy. Our goal is to perform a prospective analysis to compare the diagnostic yield and safety profile of these 2 new EUS needle.

Conditions

EUS Guided Biopsy

Outcome Measures

Primary Outcomes (1)

• Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained?

  A pathologist blinded to clinical information will access each Biopsy specimen for adequacy (scoring system where scores of 0 were samples with no material, 1 - sufficient material for adequate histological interpretation, low quality (total material \<10x power field in length), 2 - sufficient material for adequate histological interpretation, high quality (\>10x power field in length)

  12 months

Secondary Outcomes (2)

• Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Diagnostic Accuracy?

  12 months

• Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Number of Needle Passes Required to Obtain the Tissue Sample?

  12 months

Study Arms (2)

Fork-tip Needle

ACTIVE COMPARATOR

Device: Fork-tip Needle

Franseen Needle

ACTIVE COMPARATOR

Device: Franseen Needle

Interventions

Fork-tip Needle DEVICE

Fork-tip Needle will be used to obtain biopsy

Fork-tip Needle

Franseen Needle DEVICE

Franseen Needle will be used to obtain biopsy

Franseen Needle

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients schedule for EUS guided biopsy

You may not qualify if:

• Patients who had EUS-FNA for cystic fluid aspiration
• Pregnant females
• International normalized ratio \>1.5 and platelet count \< 50,000
• Medically unstable

Sponsors & Collaborators

• Henning Gerke: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52402, United States

Location

Related Publications (1)

• Ashat M, Klair JS, Rooney SL, Vishal SJ, Jensen C, Sahar N, Murali AR, El-Abiad R, Gerke H. Randomized controlled trial comparing the Franseen needle with the Fork-tip needle for EUS-guided fine-needle biopsy. Gastrointest Endosc. 2021 Jan;93(1):140-150.e2. doi: 10.1016/j.gie.2020.05.057. Epub 2020 Jun 9.

  PMID: 32526235 DERIVED

Results Point of Contact

• Title: Dr. Henning Gerke
• Organization: University of Iowa Hospitals and Clinics

henning-gerke@uiowa.edu

319-384-6582

Study Officials

• Henning Gerke, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Clinical Professor

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 14, 2018
• Study Start: October 29, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)