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| Name | Class |
|---|---|
| Borland Groover Clinic, Jacksonville, FL | UNKNOWN |
| Northwestern University | OTHER |
| Mayo Clinic | OTHER |
| Montefiore Medical Center, Bronx, NY |
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All patients will receive standard medical care and no experimental interventions will be performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different size and types of aspiration and core biopsy needles.
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure commonly used for the investigation of lesions within or adjacent to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different size and types of aspiration and core biopsy needles. More recently, a novel through-the-needle microforceps has been introduced. The MorayTM microforceps fits through a 19-gauge FNA needle and allows targeted tissue sampling under EUS visualization.
Aim - To prospectively evaluate the safety and diagnostic yield of the through-the-needle microforceps for pancreatic and non-pancreatic solid, cystic and mixed solid/cystic lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic ultrasound- (EUS) guided tissue sampling | All patients scheduled to undergo EUS with tissue sampling (TS) as medically indicated will be considered for the study. Patients in whom EUS-TS is considered as part of their standard medical care will be offered to participate in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound- (EUS) guided tissue sampling | Other | EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall diagnostic yield of EUS-TS | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Yield of EUS-guided tissue sampling solid lesions | 2 months | |
| Diagnostic Yield of EUS-guided tissue sampling cystic lesions | 2 months | |
| Diagnostic yield of EUS-TS using through-the-needle micro forceps |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include all patients who are scheduled to undergo EUS-guided tissue sampling as part of their standard of care.
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Yang, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30471456 | Derived | Yang D, Trindade AJ, Yachimski P, Benias P, Nieto J, Manvar A, Ho S, Esnakula A, Gamboa A, Sethi A, Gupte A, Khara HS, Diehl DL, El Chafic A, Shah J, Forsmark CE, Draganov PV. Histologic Analysis of Endoscopic Ultrasound-Guided Through the Needle Microforceps Biopsies Accurately Identifies Mucinous Pancreas Cysts. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1587-1596. doi: 10.1016/j.cgh.2018.11.027. Epub 2018 Nov 22. |
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Computer-based files will only be made available to personnel involved in the study through the use of access privileges, passwords and encryption. The prospectively maintained database will be constructed with the Research Electronic Data Capture software.
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| UNKNOWN |
| Columbia University | OTHER |
| Johns Hopkins University | OTHER |
| New York University | OTHER |
| Yale University | OTHER |
| Geisinger Medical Center, Danville, PA | UNKNOWN |
| Ochsner Health System | OTHER |
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| 2 months |
| Diagnostic yield of EUS-TS using fine-needle aspiration | 2 months |
| Diagnostic yield of EUS-TS using core biopsy needle | 2 months |
| Rate of adverse events associated with EUS-TS | Adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE) | 48 hours |