EUS-FNB for Solid Pancreatic Lesions: Side-fenestrated Vs Fork-tip Needle

NCT03622229 | Completed

• 1 other identifier: 1823CESC
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 2

Brief Summary

Rationale: Until now there are no prospective studies comparing the 22 gauge and 25 gauge side-fenestrated and fork-tip needles. In the present study we will compare the two types of needles in terms of histological yield for the evaluation of solid pancreatic lesions in the absence of rapid on-site evaluation (ROSE). Moreover diagnostic accuracy and the number of passes necessary to achieve the maximum diagnostic and histological yield, and safety will be investigated. Objectives: To evaluate and compare the histologic retrieval rate of two different EUS-FNB needles of the same caliber (22 or 25 gauge). The passes will be 3 for each patient. Study design: Randomized monocentric trial. Study population: Patients ≥18 years old, referred for EUS-guided tissue sampling of a solid pancreatic mass. Intervention: EUS-guided tissue acquisition by mean EUS-FNB, using one of the following FNB needles: side-fenestrated 22 gauge, side-fenestrated 25 gauge, fork-tip 22 gauge or fork-tip 25 gauge. Main study parameters/endpoints: The main endpoint is the histologic yield (defined as the percentage of a tissue core of at least 550 micron at the greatest axis), obtained at each of the 3 needle passes. Secondary endpoints include: i) safety; ii) concordance between macroscopic on-site evaluation (MOSE) and histopathological evaluation ; iii) Accuracy using 1, 2 or 3 passes.

Conditions

Biopsy, Fine-needle; Pancreatic Neoplasm

Keywords

pancreatic cancer, endoscopic ultrasound, fine needle biopsy

Outcome Measures

Primary Outcomes (1)

• EUS-FNB procurement yield of tissue "core" using two different FNB needles.

  Procurement percentage of a "core" (defined as a piece of tissue at least 550 micron in the greatest axis) in the two arms.

  6 months

Secondary Outcomes (8)

• Diagnostic accuracy.

  6 months

• Diagnostic accuracy according to the number of needle passes

  6 months

• Histologic retrieval rate according to the number of needle passes

  6 months

• Procedure related adverse events

  6 months

• Procedure related serious adverse events.

  6 months

Study Arms (2)

EUS-FNB with side-fenestrated needle

ACTIVE COMPARATOR

Before randomization, the endosonographer chooses the needle gauge to perform biopsy preferring the 25 gauge caliber for "difficult" lesions. The needle advances inside the lesion and the operator will perform some needle movements back and forth into the lesion while slowly withdrawn the stylet (slow-pull technique). If possible the direction of the needle inside the lesion will be changed during the movements (fanning technique) to sample different areas of the lesion. Three needle passes will be performed and the material acquired at each pass will be placed directly in formalin in a single vial. Diagnostic Test: Histologic evaluation

Diagnostic Test: Histologic evaluation

EUS-FNB with fork-tip needle

ACTIVE COMPARATOR

Intervention: like above. Diagnostic Test: Histologic evaluation.

Diagnostic Test: Histologic evaluation

Interventions

Histologic evaluation DIAGNOSTIC_TEST

Samples collected by EUS-FNB without ROSE will be processed as histologic samples

EUS-FNB with fork-tip needle; EUS-FNB with side-fenestrated needle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Solid pancreatic mass referred for EUS-guided tissue acquisition.
• Written informed consent.

You may not qualify if:

• Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP).
• Cystic lesions even with solid component.
• Previous histological or cytological diagnosis.
• Pancreatic lesion not seen at EUS.
• Technical impossibility to perform EUS-FNB (for example, for the interposition of vessels).
• Patients in an emergency situation.
• Pregnancy or feeding time.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (2)

Stefano Francesco Crinò

Verona, 37100, Italy

Location

Azienda Ospedaliera Integrata Verona

Verona, 37134, Italy

Location

Related Publications (1)

• Crino SF, Le Grazie M, Manfrin E, Conti Bellocchi MC, Bernardoni L, Granato A, Locatelli F, Parisi A, Di Stefano S, Frulloni L, Larghi A, Gabbrielli A. Randomized trial comparing fork-tip and side-fenestrated needles for EUS-guided fine-needle biopsy of solid pancreatic lesions. Gastrointest Endosc. 2020 Sep;92(3):648-658.e2. doi: 10.1016/j.gie.2020.05.016. Epub 2020 May 17.

  PMID: 32433914 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Stefano Francesco Crinò

  Azienda Ospedaliera Integrata Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 9, 2018
• Study Start: November 1, 2018
• Primary Completion: December 13, 2019
• Study Completion: August 30, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

IT (2)