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The purpose of this study is to compare the diagnosis accuracy of 22G EUS Procore fine needle biopsy （FNB）device and 20G EUS Procore fine needle biopsy device for solid pancreatic lesions.
This is a single-blind, randomized, controlled trial. One thousand two hundred and twenty four patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to 4 arms. For arm A1 which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is slow pull(SP)-modified wet suction technique(MWST)-slow pull(SP)-modified wet suction technique(MWST). For arm A2 with 22G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. For arm B1 with 20G EUS Procore fine needle biopsy device, the pass sequence is SP-MWST-SP-MWST. For arm B2 with 20G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. All procedures will be performed by experienced echoendoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 22G+SP | Other | Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST. |
|
| Arm 22G+MWST | Other | Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP. |
|
| Arm 20G+SP | Other | Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST. |
|
| Arm 20G+MWST | Other | Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Using 22G FNB, the first pass is SP | Device | Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic yields | The investigators' primary outcome measure is to compare the diagnostic yields of 22G FNB and 20G FNB to the solid pancreatic lesions. | up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| the tissue integrity | The investigators' secondary outcome measure is to assess the tissue size under a light microscope to compare the tissue obtained by 22G FNB and 20G FNB with Slow-pull or modified wet suction technique. | up to 15 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Cheng | Contact | +862783663333 | b.cheng@tjh.tjmu.edu.cn | |
| Yun Wang | Contact | +862783663333 | 820308045@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Bin Cheng | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bin Cheng | Wuhan | Hubei | 430030 | China |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15855973 | Result | DeWitt J, Jowell P, Leblanc J, McHenry L, McGreevy K, Cramer H, Volmar K, Sherman S, Gress F. EUS-guided FNA of pancreatic metastases: a multicenter experience. Gastrointest Endosc. 2005 May;61(6):689-96. doi: 10.1016/s0016-5107(05)00287-7. | |
| 22658389 | Result | Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31. |
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| Using 22G FNB, the first pass is MWST | Device | Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP. |
|
| Using 20G FNB, the first pass is SP | Device | Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST. |
|
| Using 20G FNB, the first pass is MWST | Device | Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.technique-slow pull. |
|
| 28440232 | Result | Ge N, Zhang S, Jin Z, Sun S, Yang A, Wang B, Wang G, Xu G, Hao J, Zhong L, Zhong N, Li P, Zhu Q, Nian W, Li W, Zhang X, Zhou X, Yang X, Cui Y, Ding Z. Clinical use of endoscopic ultrasound-guided fine-needle aspiration: Guidelines and recommendations from Chinese Society of Digestive Endoscopy. Endosc Ultrasound. 2017 Mar-Apr;6(2):75-82. doi: 10.4103/eus.eus_20_17. No abstract available. |
| 20427392 | Result | Gleeson FC, Kipp BR, Caudill JL, Clain JE, Clayton AC, Halling KC, Henry MR, Rajan E, Topazian MD, Wang KK, Wiersema MJ, Zhang J, Levy MJ. False positive endoscopic ultrasound fine needle aspiration cytology: incidence and risk factors. Gut. 2010 May;59(5):586-93. doi: 10.1136/gut.2009.187765. |
| 28733257 | Result | Cheng B, Zhang Y, Chen Q, Sun B, Deng Z, Shan H, Dou L, Wang J, Li Y, Yang X, Jiang T, Xu G, Wang G. Analysis of Fine-Needle Biopsy vs Fine-Needle Aspiration in Diagnosis of Pancreatic and Abdominal Masses: A Prospective, Multicenter, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1314-1321. doi: 10.1016/j.cgh.2017.07.010. Epub 2017 Jul 19. |
| 25733127 | Result | Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27. |
| 26879162 | Result | Villa NA, Berzosa M, Wallace MB, Raijman I. Endoscopic ultrasound-guided fine needle aspiration: The wet suction technique. Endosc Ultrasound. 2016 Jan-Feb;5(1):17-20. doi: 10.4103/2303-9027.175877. |
| 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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