EUS-FNB With MOSE vs EUS-FNA With ROSE

Pancreatic Neoplasms Clinical Trial

— MORE  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03766659
• Other study ID #: MORE
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: Charing CHONG
• Phone: 3505 3933
• Email: chongcn[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: September 1, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• MOSE
EUS-FNB with MOSE
• ROSE
EUS-FNA with ROSE

Locations

Country	Name	City	State
Hong Kong	Department of Surgery; The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	the proportion of patients with adequate tissue for diagnosis	1 month after Procedure
Secondary	morbidity rate	Procedure-related morbidity	1 month after Procedure