SharkCore Versus Acquire FNB

Randomized Controlled Trial Comparing the Franseen Needle With a Fork-tip Needle for EUS-guided Fine Needle Biopsy

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.

Study Overview

• Status: Completed
• Conditions: EUS Guided Biopsy
• Intervention / Treatment: Device: Fork-tip Needle; Device: Franseen Needle

Detailed Description

Subjects will come to a pre-procedure room on the day of the procedure. The investigator will again go over the risk and benefit of procedure and indication of the procedure. Once the consent form is signed, a large bore IV cannula is placed and the subject will be taken to the DHC procedure room. Once all the team members required to perform the procedure are in the room we will do a time-out to make sure current patient and procedure are performed. A time-out is done by asking the subject to tell his full name with date of birth and describe in his own words what procedure is planned for subject today. If all the things match the investigator will go ahead and start the sedation.

All EUS-FNB will be performed in the standard manner using linear echoendoscopes. All EUS-FNB procedures were performed by 1 of 2 highly experienced endosonographers (Henning Gerke or Rami EL-Abiad).

The needle to be used (SharkCore vs Acquire) will be decided based on randomization software. The needle will then be used to puncture the target lesion in standard fashion. Aspirated cellular materials will be expressed into the slide by advancing the stylet. The remainder will be expressed onto filter paper and submitted for cell block preparation. The subject's medical information including diagnosis, date of diagnosis, date of admission, blood test results, and medications received will be reviewed for analysis.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52402
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients schedule for EUS guided biopsy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Fork-tip Needle	Device: Fork-tip Needle; Fork-tip Needle will be used to obtain biopsy
ACTIVE_COMPARATOR: Franseen Needle	Device: Franseen Needle; Franseen Needle will be used to obtain biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Diagnostic Accuracy?	The diagnostic accuracy was calculated considering malignant diagnoses as a true positive. A histological or cytological diagnosis of a neoplastic lesion will be considered correct since false-positive diagnoses have been reported to be rare if strict cytological criteria are applied. The criterion standard for diagnosis of benign, non-neoplastic lesion that will not undergo surgical resection will be based on a combination of clinal impression, imaging characteristics and a clinical course that was consistent with the study diagnosis.	12 months
Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Number of Needle Passes Required to Obtain the Tissue Sample?	We will be collecting data on how many needle passes are required to get adequate FNB sample for each procedure. In the end, we will use this data to calculate using standard statistical measures to compare the average number of passes required to get adequate sample by both SharkCore and Acquire needle.	12 months

Collaborators and Investigators

• Sponsor: Henning Gerke
• Investigators: Principal Investigator: Henning Gerke, MD, University of Iowa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2018
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (ACTUAL): September 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 201808820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not be sharing IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes