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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOSE | Other | EUS-FNB with MOSE |
|
| ROSE | Other | EUS-FNA with ROSE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOSE | Diagnostic Test | EUS-FNB with MOSE |
| |
| ROSE |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | the proportion of patients with adequate tissue for diagnosis | 1 month after Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| morbidity rate | Procedure-related morbidity | 1 month after Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charing CHONG | Contact | 3505 3933 | chongcn@surgery.cuhk.edu.hk | |
| Philip Yeung | Contact | 3404 3933 | philipyeung@surgery.cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery; The Chinese University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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International multicenter prospective randomized comparative study.
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| Diagnostic Test |
EUS-FNA with ROSE |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |