Motorized Fine Needle Biopsy vs Standard Needles

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298604
• Other study ID #: IECED-12112023
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2023
• Est. completion date: December 9, 2024

Study information

• Verified date: March 2024
• Source: Instituto Ecuatoriano de Enfermedades Digestivas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 9, 2024
• Est. primary completion date: October 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Diseases
• Pancreas Disease
• Pancreatic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Ecuador	Instituto Ecuatoriano de Enfermedades Digestivas (IECED)	Guayaquil

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Ecuatoriano de Enfermedades Digestivas

Country where clinical trial is conducted

Ecuador, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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