Motorized Fine Needle Biopsy vs Standard Needles

Comparison Between a Novel Motorized EUS Guided Fine Needle Biopsy (FNB) With Standard Needle for Pancreatic and Liver Biopsies

Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition.

Given the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.

Study Overview

• Status: Recruiting
• Conditions: Liver Diseases; Pancreas Disease
• Intervention / Treatment: Device: EUS-guided standard fine needle biopsy; Device: EUS-guided motorized fine needle biopsy

Detailed Description

The development of Endoscopic ultrasound-guided tissue acquisition (EUS-TA) has been remarkable. Initially focused on obtaining samples from the pancreas, it has expanded significantly to include various organs adjacent to the gastrointestinal system (i.e., liver, lymph nodes, adrenal glands).

One of the key advancements in EUS-TA involves the shift from cytological analysis, with fine-needle aspiration (FNA), to histological and even genetic evaluations, with fine-needle biopsies (FNB). FNB addresses some limitations associated with FNA, such as low tumor cellularity and the inability to retain cellular architecture.

Recent improvements in puncture techniques and needles, allow for the collection of high-quality specimens, comparable to core needle biopsy, to achieve standards for specimen adequacy (i.e., intact liver cores of at least 15-20 mm with a complete portal triad count of 11). Some current available needle designs include the crown type, flanged type, 20 Gauge FNB needles with forward-faced core traps, and the fork-tip needles, demonstrating high diagnostic accuracy and a low rate of adverse events.

The Precision-GI is a new motorized fine needle (mFNB) developed by LIMACA Medical in Israel for EUS-guided FNB. It operates using a battery-powered motor that enables controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition. Moreover, a sharp stylet facilitates crossing through the gastrointestinal wall, allowing for the reach of target lesions. The rotational electromechanical cutting movement into the lesion promises intact motorized tissue acquisition without sample damage.

In the present study, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of EUS-guided pancreatic and liver specimens. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ecuador
  • Guayaquil, Ecuador, 090505
    • Recruiting
    • Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
    • Principal Investigator: Carlos Robles-Medranda, MD FASGE
    • Sub-Investigator: Martha Arevalo-Mora, MD
    • Sub-Investigator: Juan Alcivar-Vasquez, MD
    • Sub-Investigator: Maria Egas-Izquierdo, MD
    • Sub-Investigator: Miguel Puga-Tejada, MD
    • Sub-Investigator: Jorge Baquerizo-Burgos, MD
    • Sub-Investigator: Domenica Cunto, MD
    • Sub-Investigator: Raquel Del Valle, MD
    • Contact: Carlos Robles-Medranda, MD FASGE; Phone Number: +593989158865; Email: carlosoakm@yahoo.es
    • Sub-Investigator: Hannah Pitanga-Lukashok, MD
    • Sub-Investigator: Daniela Tabacelia, MD
    • Sub-Investigator: Gustavo Rubio, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients between 18 and 99 years
• Patients referred to our center who require EUS-guided liver or pancreas biopsy.
• Male or female patients.
• Patients able to give consent

Exclusion Criteria:

• Pregnancy or nursing
• Patients with coagulation disorders (platelets <50.000/mm3, international normalised ratio (INR) >2)
• Any underlying medical condition that contraindicates EUS-guided fine needle biopsy such as anatomical alterations, significant gastric outlet obstruction, collateral intervening vessels.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard EUS-guided FNB; Patients scheduled for EUS-guided liver or pancreas biopsy will undergo the procedure using a standard 19-gauge needle	Device: EUS-guided standard fine needle biopsy; Using the echoendoscope, a pancreatic lesion or liver parenchyma will be identified, and a 19-gauge standard fine needle biopsy device (Boston Scientific, USA) is inserted on it to obtain the sample or specimen.
Experimental: Motorized EUS-guided FNB; Patients scheduled for EUS-guided liver or pancreas biopsy will undergo the procedure using a motorized 20-gauge needle.	Device: EUS-guided motorized fine needle biopsy; Using the echoendoscope, a pancreatic lesion or liver parenchyma will be identified, and a 20-gauge motorized fine needle biopsy device (Limaca, Israel) is inserted on it to obtain the sample or specimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic ultrasound fine needle biopsy sample quality	Based on tissue "core"; Tissue core is defined as a architecturally intact piece of at least 550 micron in the greatest axis. The tissue core will be evaluated in both groups by the pathologist immediately after its acquisition.	Up to two hours after the procedures
Diagnostic accuracy according to histological analysis	Proportion of subjects with a definitive diagnosis based on the number of passes and throws for tissue acquisition.	Up to one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue blood contamination	Evaluation of tissue blood contamination will be based on a sample quality score: Only blood; High (>50% of the surface of the slide); Moderate (25%-50% of the surface of the slide); Low (<25% of the surface of the slide)	Up to one hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time efficiency during tissue acquisition	The tissue from identifying the lesion to obtaining the sample. It will be calculated in minutes	Up to two hours
Quality of cytologic sample	The quality of the cytologic sample will be scored according to the pathologist criteria as: 0= insufficient material for cytologic interpretation; sufficient material for limited cytologic interpretation; sufficient material for adequate cytologic interpretation	Up to 2 hours
Rate of liver specimen adequacy	Intact liver cores of at least 15-20 mm with a complete portal triad count of 11	Up to 1 week
Rate of adverse events associated with the procedure	Adverse event associated with the procedure, including transprocedural, early, and late post-procedural occurrence	Up to 6 months

Collaborators and Investigators

• Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas

Publications and helpful links

General Publications

• Mendoza Ladd A, Casner N, Cherukuri SV, Garcia C, Padilla O, Dwivedi A, Hakim N. Fine Needle Biopsies of Solid Pancreatic Lesions: Tissue Acquisition Technique and Needle Design Do Not Impact Specimen Adequacy. Dig Dis Sci. 2022 Sep;67(9):4549-4556. doi: 10.1007/s10620-021-07316-4. Epub 2021 Dec 2.
• Di Mitri R, Mocciaro F, Antonini F, Scimeca D, Conte E, Bonaccorso A, Scibetta N, Unti E, Fornelli A, Giorgini S, Binda C, Macarri G, Larghi A, Fabbri C. Stylet slow-pull vs. standard suction technique for endoscopic ultrasound-guided fine needle biopsy in pancreatic solid lesions using 20 Gauge Procore needle: A multicenter randomized trial. Dig Liver Dis. 2020 Feb;52(2):178-184. doi: 10.1016/j.dld.2019.08.023. Epub 2019 Oct 7.
• Fujita A, Ryozawa S, Tanisaka Y, Ogawa T, Saito Y, Katsuda H, Miyaguchi K, Yasuda M, Araki R, Mashimo Y, Tashima T, Nakano Y, Terada R, Jinushi R, Mizuide M. Comparison of Fork-tip and Franseen needles for endoscopic ultrasound-guided fine-needle biopsy in pancreatic solid lesions: A propensity-matched analysis. DEN Open. 2022 Jun 28;3(1):e147. doi: 10.1002/deo2.147. eCollection 2023 Apr.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2023
• Primary Completion (Estimated): October 9, 2024
• Study Completion (Estimated): December 9, 2024

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pancreas; liver; pathology; Endosonography; Fine-needle biopsy
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Pancreatic Diseases
• Other Study ID Numbers: IECED-12112023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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