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To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.
Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis.
Regarding the diagnosis of pancreatic cancer, proper tool with high diagnostic yield is very important. The investigators investigated the technical feasibility and diagnostic yield of recent-developed new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.
The investigators applied the 20-gauge procore needle for EUS-guided fine needle biopsy in the diagnosis of pancreatic solid mass. A total of 30 patients will be enrolled for the present pilot study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | EUS-FNB using 20-gauge procore needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20-gauge ProCore FNB needle | Device | The investigators will prospectively collect data base including patients who underwent EUS-guided biopsy with the 20-gauge ProCore histology needle for the evaluation of Pancreatic solid mass. EUS procedures will be performed under sedation with linear echoendoscopes. Once the lesion will be penetrated, the stylet will be removed, and suction will be applied for 10 to 20 seconds by using a 10-ml syringe while moving the needle to and fro. All samples will processed at the pathology departments for histological analysis with documentation. |
| Measure | Description | Time Frame |
|---|---|---|
| Procurement of the histologic core | The sample quality is evaluated as optimal for histological evaluation; the presence of optimal histological core including recognizable structures | 7 days after the procedure |
| Diagnostic accuracy | [Standard diagnosis]
| 7 days after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Technical failure is defined as malfunction of the needle before the investigators reached a diagnosis | 7 days after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19669880 | Background | Lee JH, Stewart J, Ross WA, Anandasabapathy S, Xiao L, Staerkel G. Blinded prospective comparison of the performance of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of the pancreas and peri-pancreatic lesions. Dig Dis Sci. 2009 Oct;54(10):2274-81. doi: 10.1007/s10620-009-0906-1. Epub 2009 Aug 11. | |
| 19640524 |
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| Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28. |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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