EUS-FNB With MOSE vs EUS-FNA With ROSE

Not Applicable

Recruiting

• Conditions: Pancreatic Neoplasms
• Interventions: Diagnostic Test: ROSE; Diagnostic Test: MOSE

• Registration Number: NCT03766659
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Study Start: 2019-06-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13
• Primary Completion: 2023-08-31
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ROSE	ROSE	EUS-FNA with ROSE
MOSE	MOSE	EUS-FNB with MOSE

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	1 month after Procedure	the proportion of patients with adequate tissue for diagnosis

Secondary Outcome Measures

Name	Time	Method
morbidity rate	1 month after Procedure	Procedure-related morbidity

Trial Locations

Locations (1)

Department of Surgery; The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong