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2019-06-19
2023-08-31
2024-09-01
340
NCT03766659
Chinese University of Hong Kong
Chinese University of Hong Kong
INTERVENTIONAL
EUS-FNB With MOSE vs EUS-FNA With ROSE
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for tissue acquisition for pancreatic lesions. However, FNA alone has several limitations including inadequate acquisition of cells, and unable to provide core tissue for further histological analysis. The use of rapid on-site evaluation (ROSE) by cytopathologist has the biggest impact on improving diagnostic accuracy and is regarded as the gold standard for EUS-FNA. Unfortunately, it is not widely available due to limited resources. In order to overcome these limitations, new fine needle biopsy (FNB) needles have been recently developed to collect not only cells but also the entire core tissue for histological analysis. Having core biopsy with preserved tissue provides additional advantages of allowing molecular analysis, which are of emerging importance in cancer management. Early results comparing FNB with FNA showed the superiority of FNB over FNA in the absence of ROSE. Data comparing FNB and FNA with ROSE are limited. In order to study to true merits of FNB over FNA, comparison with the most optimal method is necessary.
The purpose of this study is to compare the diagnostic yield of EUS-FNB with MOSE vs EUS-FNA with ROSE.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-12-05 | N/A | 2023-02-09 |
2018-12-05 | N/A | 2023-02-13 |
2018-12-06 | N/A | 2023-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: MOSE EUS-FNB with MOSE | DIAGNOSTIC_TEST: MOSE
|
| OTHER: ROSE EUS-FNA with ROSE | DIAGNOSTIC_TEST: ROSE
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Diagnostic yield | the proportion of patients with adequate tissue for diagnosis | 1 month after Procedure |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| morbidity rate | Procedure-related morbidity | 1 month after Procedure |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Charing CHONG Phone Number: 3505 3933 Email: chongcn@surgery.cuhk.edu.hk |
Study Contact Backup Name: Philip Yeung Phone Number: 3404 3933 Email: philipyeung@surgery.cuhk.edu.hk |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
