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

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Completed

Conditions

Solid Tumor

Treatments

Other: Control
Procedure: Macroscopic on-site evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT03130140
2015.511

Details and patient eligibility

About

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.

Full 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.

Enrollment

244 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

244 participants in 2 patient groups

Macroscopic on-site evaluation
Active Comparator group
Description:
EUS-FNA perform with a 19-gauge needle with macroscopic on-site evaluation.
Treatment:
Procedure: Macroscopic on-site evaluation
Control
Sham Comparator group
Description:
EUS-FNA perform with a 19-gauge needle with conventional techniques.
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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