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Completed

NCT Number: NCT03130140

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

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.

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Key information

Conditions

Solid Tumor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

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

Treatment and study plan

Macroscopic on-site evaluation

Procedure

Macroscopic on-site evaluation: any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). Length of MVC will be measured to determine the adequacy of that puncture.

Control

Other

Conventional EUS-FNA

Primary outcomes

  1. Diagnostic yield: Proportion of patients with adequate tissue for diagnosis obtained by EUS FNA

    Time frame: 4 weeks

    proportion of patients with adequate tissue for diagnosis obtained by EUS FNA

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Macroscopic On-site Quality Evaluation of Biopsy Specimens to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions: a Multicenter Prospective Randomized Controlled Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2017
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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