EUS-FNB With MOSE vs EUS-FNA With ROSE
MORE
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)
1 other identifier
interventional
340
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2018
CompletedFirst Posted
Study publicly available on registry
December 6, 2018
CompletedStudy Start
First participant enrolled
June 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedFebruary 13, 2023
February 1, 2023
4.2 years
December 5, 2018
February 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic yield
the proportion of patients with adequate tissue for diagnosis
1 month after Procedure
Secondary Outcomes (1)
morbidity rate
1 month after Procedure
Study Arms (2)
MOSE
OTHEREUS-FNB with MOSE
ROSE
OTHEREUS-FNA with ROSE
Interventions
Eligibility Criteria
You may qualify if:
- Aged between 18 and 80 years
- Referred for EUS-guided tissue acquisition of solid pancreatic lesions greater than 1cm in the largest diameter
You may not qualify if:
- Coagulopathy
- Altered anatomy
- Contraindications for conscious sedation
- Pregnancy
- Those who cannot provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery; The Chinese University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
December 5, 2018
First Posted
December 6, 2018
Study Start
June 19, 2019
Primary Completion
August 31, 2023
Study Completion
September 1, 2024
Last Updated
February 13, 2023
Record last verified: 2023-02