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

December 4, 2018 updated by: Charing Chong, MD, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Macroscopic on-site evaluation
EUS-FNA perform with a 19-gauge needle with macroscopic on-site evaluation.
Procedure: Macroscopic on-site evaluation
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.
Sham Comparator: Control
EUS-FNA perform with a 19-gauge needle with conventional techniques.
Other: Control
Conventional EUS-FNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2015.511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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