EUS-FNB With MOSE vs EUS-FNA With ROSE

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

Official Title
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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)

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Diagnostic Test: MOSE
* Diagnostic Test: ROSE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: International multicenter prospective randomized comparative study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MOSE<br>EUS-FNB with MOSE | Diagnostic Test: MOSE<br>* EUS-FNB with MOSE<br>|
| Other: ROSE<br>EUS-FNA with ROSE | Diagnostic Test: ROSE<br>* EUS-FNA with ROSE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | the proportion of patients with adequate tissue for diagnosis | 1 month after Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity rate | Procedure-related morbidity | 1 month after Procedure |