Motorized Fine Needle Biopsy vs Standard Needles

NCT06298604 | Recruiting

• 1 other identifier: IECED-12112023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreas Disease; Liver Diseases

Keywords

Fine-needle biopsy; Endosonography; liver; pancreas; pathology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Tissue blood contamination

  Up to one hour

Other Outcomes (4)

• Time efficiency during tissue acquisition

  Up to two hours

• Rate of liver specimen adequacy

  Up to 1 week

• Rate of adverse events associated with the procedure

  Up to 6 months

Study Arms (2)

Standard EUS-guided FNB

ACTIVE COMPARATOR

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

Motorized EUS-guided FNB

EXPERIMENTAL

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

Interventions

EUS-guided standard fine needle biopsy DEVICE

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.

Standard EUS-guided FNB

EUS-guided motorized fine needle biopsy DEVICE

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.

Motorized EUS-guided FNB

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

Guayaquil, 090505, Ecuador

RECRUITING

Related Publications (3)

• 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.

  PMID: 34859313 BACKGROUND

• 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.

  PMID: 31601535 BACKGROUND

• 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.

  PMID: 35898843 BACKGROUND

MeSH Terms

Conditions

Pancreatic Diseases; Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Single masking, the pathologist will be blinded to the needle used for sample collection.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Endoscopy Division

Model Details: Prospective, diagnostic,, cross-sectional study

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: December 9, 2023
• Primary Completion: October 9, 2024
• Study Completion: December 9, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

EC (1)