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| Name | Class |
|---|---|
| Hvidovre University Hospital | OTHER |
| Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania | UNKNOWN |
| Endoscopy Unit, Odense Hospital, Denmark | UNKNOWN |
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The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FNA | Active Comparator |
| |
| FNB | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProControl, MediGlobe | Device | standard 22G FNA needle |
| |
| TopGain, Medi-Globe |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of tissue micro-fragments | Comparison of median number of tissue micro-fragments | 1 month |
| Diagnostic tissue area | Comparison of total diagnostic tissue area in um2 | 1 month |
| Total tissue area | Comparison of total total tissue area in um2 | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | diagnostic yield - defined by percentage of diagnostic samples in each group | 1 month |
| Diagnostic performance | Sensitivity and specificity, where final diagnosis is either established by subsequent histopathological confirmation or other evidence (clinical, radiological) of malignant disease at a minimum of 12 months of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bojan Kovacevic | Contact | +4538686312 | bojan.kovacevic@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastro Unit, Division of Endoscopy | Recruiting | Herlev | Danmark | 2730 | Denmark |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 28, 2023 | |
| Reset | Dec 6, 2023 | |
| Release | Dec 13, 2023 | |
| Reset | Dec 14, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 28, 2023 | Dec 6, 2023 | |||
| Dec 13, 2023 |
| 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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| Device |
novel 22G crown-cut FNB needle |
|
| 12 month |
| Adverse event rate | Comparison of proportions of patients experiencing AE in each group as defined by ASGE's lexicon on adverse events in endoscopy | 1 month |
| Mean DNA concentration | 6 months |
| Suitability for molecular analyses | Percentage of samples where NGS analysis was successful | 6 months |
| Dec 14, 2023 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |