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Clinical Trials/NCT03766659
NCT03766659
Recruiting
Not Applicable

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)

Chinese University of Hong Kong1 site in 1 country340 target enrollmentJune 19, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreatic Neoplasms
Sponsor
Chinese University of Hong Kong
Enrollment
340
Locations
1
Primary Endpoint
Diagnostic yield
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 19, 2019
End Date
September 1, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Charing Chong, MD

Dr

Chinese University of Hong Kong

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diagnostic yield

Time Frame: 1 month after Procedure

the proportion of patients with adequate tissue for diagnosis

Secondary Outcomes

  • morbidity rate(1 month after Procedure)

Study Sites (1)

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