EUS-FNB With MOSE vs EUS-FNA With ROSE

NCT ID: NCT03766659

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-19

Study Completion Date

2024-09-01

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.

Conditions

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Pancreatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

International multicenter prospective randomized comparative study.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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MOSE

EUS-FNB with MOSE

Group Type OTHER

MOSE

Intervention Type DIAGNOSTIC_TEST

EUS-FNB with MOSE

ROSE

EUS-FNA with ROSE

Group Type OTHER

ROSE

Intervention Type DIAGNOSTIC_TEST

EUS-FNA with ROSE

Interventions

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MOSE

EUS-FNB with MOSE

Intervention Type DIAGNOSTIC_TEST

ROSE

EUS-FNA with ROSE

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Charing Chong, MD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Surgery; The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Charing CHONG

Role: CONTACT

3505 3933

Philip Yeung

Role: CONTACT

3404 3933

Facility Contacts

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Charing C Chong, MBChB

Role: primary

852-26321496

Other Identifiers

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MORE

Identifier Type: -

Identifier Source: org_study_id

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