Is One Pass Enough for the Diagnosis of the Pancreatic Masses During EUS-FNB? (ONE PASS)

Is One Pass Enough for the Diagnosis of the Pancreatic Masses During EUS-FNB? A Prospective Study

Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Major complications after EUS-TA of solid masses are rare. Several studies have been published in the last recent years aimed to identify factors related to a non-diagnostic or false-negative EUS-FNA, and to improve its diagnostic yield using different needle gauge and different tissue acquisition technique as fanning technique, slow-pull stylet extraction or suction technique.

To overcome this problem, new EUS-TA needles entered in clinical practice to obtain histological specimens increasing the accuracy of the EUS-TA. Preliminary result with these new needles, called EUS-fine needle biopsy (FNB) are promising with an accuracy rate more than 90%.

Recently, Leungh et al. conducted an observational study to evaluate the role of macroscopic on-site evaluation (MOSE) on the diagnostic accuracy of 22G Franseen-tip needle. The study demonstrated that MOSE using the 22G Franseen tip needle could limit needle passes by accurately estimating histologic core fragments. However, the study limitations such as the small sample size and the lack of control group, hampered the value of the conclusions.

So, nowadays, no definitive data regarding how many needle passes need to be performed with FNB needles, neither regarding the use of MOSE to evaluate the specimens obtained with FNB needle. The MOSE technique of the acquired tissue was proposed for the first time by Iwashita et al, using a 19G needle and is nowadays a well-established technique with high accuracy in the final diagnosis.

The aim of our study is to evaluate if during EUS-FNB of pancreatic masses only one needle pass with MOSE evaluation can be satisfactory to obtain a correct diagnosis.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Procedure: EUS-FNB

• Study Type: Observational
• Enrollment (Anticipated): 79

Contacts and Locations

Study Locations

• Italy
  • Castellanza, Italy, 21053
    • Humanitas-Mater Domini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

79 patients with solid pancreatic masses underwent EUS-FNB will be included.

Description

Inclusion Criteria:

• Age greater than 18, both genders.
• Both in-patient and out-patients.
• Presence of a solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
• FNB performed by a 22G needle Acquire® (Boston Scientific).
• Tissue acquisition with fanning technique.
• Able to obtained informed consent.

Exclusion Criteria:

• Patients underwent EUS-FNA with or without ROSE
• Patients underwent EUS-FNB plus ROSE.
• Previous biopsy of the lesion with diagnosis of malignancy
• Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
• Pregnancy or breast-feeding.
• Patients unable to understand and/or read the consent form.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EUS-FNB	Procedure: EUS-FNB; EUS-FNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic accuracy of one pass EUS-FNB.	EUS-FNB only one needle pass inside the target lesions with MOSE evaluation can be satisfactory to obtain a correct diagnosis.	24 months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas Mater Domini
• Investigators: Principal Investigator: Benedetto Mangiavillano, MD, benedetto.mangiavillano@mc.humanitas.it

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 07-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No