MOSE to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions
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
1 other identifier
interventional
244
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2016
CompletedFirst Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedDecember 6, 2018
December 1, 2018
2.5 years
April 19, 2017
December 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic yield: Proportion of patients with adequate tissue for diagnosis obtained by EUS FNA
proportion of patients with adequate tissue for diagnosis obtained by EUS FNA
4 weeks
Study Arms (2)
Macroscopic on-site evaluation
ACTIVE COMPARATOREUS-FNA perform with a 19-gauge needle with macroscopic on-site evaluation.
Control
SHAM COMPARATOREUS-FNA perform with a 19-gauge needle with conventional techniques.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese University of Hong Kong
Hong Kong, Hong Kong
Related Publications (1)
Chong CCN, Lakhtakia S, Nguyen N, Hara K, Chan WK, Puri R, Almadi MA, Ang TL, Kwek A, Yasuda I, Doi S, Kida M, Wang HP, Cheng TY, Jiang Q, Yang A, Chan AWH, Chan S, Tang R, Iwashita T, Teoh AYB. Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial. Endoscopy. 2020 Oct;52(10):856-863. doi: 10.1055/a-1172-6027. Epub 2020 Jun 4.
PMID: 32498098DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 19, 2017
First Posted
April 26, 2017
Study Start
February 26, 2016
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
December 6, 2018
Record last verified: 2018-12