MOSE to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions

Not Applicable

Completed

• Conditions: Solid Tumor
• Interventions: Procedure: Macroscopic on-site evaluation; Other: Control

• Registration Number: NCT03130140
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The technique of macroscopic on-site evaluation (MOSE) has recently been advocated for estimating the adequacy of a core specimen for histological diagnosis during EUS-FNA using a 19-gauge needle. How it compares to the conventional technique of tissue acquisition during EUS-FNA is uncertain.

The objective of this study is to evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis.

Detailed Description

To evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis in a randomized controlled study.

Study Timeline

• Study Start: 2016-02-26
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-26
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

• Consecutive patients (aged between 18 and 80 years) referred for EUS-guided tissue acquisition for intestinal or extra-intestinal solid lesions more than 2cm in the largest diameter would be included.

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Exclusion Criteria

• Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macroscopic on-site evaluation	Macroscopic on-site evaluation	EUS-FNA perform with a 19-gauge needle with macroscopic on-site evaluation.
Control	Control	EUS-FNA perform with a 19-gauge needle with conventional techniques.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield: Proportion of patients with adequate tissue for diagnosis obtained by EUS FNA	4 weeks	proportion of patients with adequate tissue for diagnosis obtained by EUS FNA

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong