EUS-FNB With MOSE vs EUS-FNA With ROSE

Endoscopic Ultrasound-guided Fine Needle Biopsy With Macroscopic On-Site Evaluation vs Fine Needle Aspiration With Rapid On-Site Evaluation for Solid Pancreatic Lesions: A Multi-centered Prospective Randomized Controlled Trial (MORE Trial)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03766659

Acronym

Enrollment

340

Registered

2018-12-06

Start date

2019-06-19

Completion date

2024-09-01

Last updated

2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Brief summary

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for tissue acquisition for pancreatic lesions. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. The use of rapid on-site evaluation (ROSE) by cytopathologist has the biggest impact on improving diagnostic accuracy and is regarded as the gold standard for EUS-FNA. Unfortunately, it is not widely available due to limited resources. In order to overcome these limitations, new fine needle biopsy (FNB) needles have been recently developed to collect not only cells but also the entire core tissue for histological analysis. Having core biopsy with preserved tissue provides additional advantages of allowing molecular analysis, which are of emerging importance in cancer management. Early results comparing FNB with FNA showed the superiority of FNB over FNA in the absence of ROSE. Data comparing FNB and FNA with ROSE are limited. In order to study to true merits of FNB over FNA, comparison with the most optimal method is necessary.

Detailed description

The purpose of this study is to compare the diagnostic yield of EUS-FNB with MOSE vs EUS-FNA with ROSE.

Interventions

DIAGNOSTIC_TESTMOSE

EUS-FNB with MOSE

DIAGNOSTIC_TESTROSE

EUS-FNA with ROSE

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Intervention model description

International multicenter prospective randomized comparative study.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Aged between 18 and 80 years * Referred for EUS-guided tissue acquisition of solid pancreatic lesions greater than 1cm in the largest diameter

Exclusion criteria

* Coagulopathy * Altered anatomy * Contraindications for conscious sedation * Pregnancy * Those who cannot provide informed consent

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic yield	1 month after Procedure	the proportion of patients with adequate tissue for diagnosis

Secondary

Measure	Time frame	Description
morbidity rate	1 month after Procedure	Procedure-related morbidity

Countries

Hong Kong

Contacts

Primary ContactCharing CHONG

chongcn@surgery.cuhk.edu.hk3505 3933

Backup ContactPhilip Yeung

philipyeung@surgery.cuhk.edu.hk3404 3933

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026