Pancreatic Neoplasms Clinical Trial
Official title:
Prospective Randomized Study Comparing the 25-gauge Franseen Needle and the 25-gauge Standard Needle for EUS-guided Fine-needle Sampling of Solid Pancreatic Lesions Without Rapid on Site Evaluation
This is a randomized study in order to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | April 2023 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - solid pancreatic lesion larger than 15 mm Exclusion Criteria: - pancreatic cystic lesion - lesion not detected in EUS - abnormal coagulation parameters (INR> 2, platelet count < 50,000) |
Country | Name | City | State |
---|---|---|---|
Brazil | ICESP | São Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Instituto do Cancer do Estado de São Paulo | Boston Scientific Corporation |
Brazil,
Bang JY, Hebert-Magee S, Hasan MK, Navaneethan U, Hawes R, Varadarajulu S. Endoscopic ultrasonography-guided biopsy using a Franseen needle design: Initial assessment. Dig Endosc. 2017 May;29(3):338-346. doi: 10.1111/den.12769. Epub 2016 Dec 20. — View Citation
Fabbri C, Polifemo AM, Luigiano C, Cennamo V, Baccarini P, Collina G, Fornelli A, Macchia S, Zanini N, Jovine E, Fiscaletti M, Alibrandi A, D'Imperio N. Endoscopic ultrasound-guided fine needle aspiration with 22- and 25-gauge needles in solid pancreatic masses: a prospective comparative study with randomisation of needle sequence. Dig Liver Dis. 2011 Aug;43(8):647-52. doi: 10.1016/j.dld.2011.04.005. Epub 2011 May 17. — View Citation
Iglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I, Larino-Noia J, Eugenyeva E, Lozano-Leon A, Forteza-Vila J. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of so — View Citation
Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Muñoz JE. Feasibility and yield of a new EUS histology needle: results from — View Citation
Itoi T, Sofuni A, Itokawa F, Irisawa A, Khor CJ, Rerknimitr R. Current status of diagnostic endoscopic ultrasonography in the evaluation of pancreatic mass lesions. Dig Endosc. 2011 May;23 Suppl 1:17-21. doi: 10.1111/j.1443-1661.2011.01132.x. Review. — View Citation
Kim HJ, Jung YS, Park JH, Park DI, Cho YK, Sohn CI, Jeon WK, Kim BI, Choi KY, Ryu S. Endosonographer's macroscopic evaluation of EUS-FNAB specimens after interactive cytopathologic training: a single-center prospective validation cohort study. Surg Endosc. 2016 Oct;30(10):4184-92. doi: 10.1007/s00464-015-4727-3. Epub 2016 Jan 7. — View Citation
Levy MJ. Endoscopic ultrasound-guided trucut biopsy of the pancreas: prospects and problems. Pancreatology. 2007;7(2-3):163-6. Epub 2007 Jun 21. — View Citation
Madhoun MF, Wani SB, Rastogi A, Early D, Gaddam S, Tierney WM, Maple JT. The diagnostic accuracy of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of solid pancreatic lesions: a meta-analysis. Endoscopy. 2013;45(2):86-92. doi: 10.1055/s-0032-1325992. Epub 2013 Jan 10. Review. — View Citation
Mohanty SK, Pradhan D, Sharma S, Sharma A, Patnaik N, Feuerman M, Bonasara R, Boyd A, Friedel D, Stavropoulos S, Gupta M. Endoscopic ultrasound guided fine-needle aspiration: What variables influence diagnostic yield? Diagn Cytopathol. 2018 Apr;46(4):293-298. doi: 10.1002/dc.23883. Epub 2017 Dec 27. — View Citation
Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392. — View Citation
Sadaf S, Loya A, Akhtar N, Yusuf MA. Role of endoscopic ultrasound-guided-fine needle aspiration biopsy in the diagnosis of lymphoma of the pancreas: A clinicopathological study of nine cases. Cytopathology. 2017 Dec;28(6):536-541. doi: 10.1111/cyt.12442. Epub 2017 Jul 24. — View Citation
Vilmann P, Jacobsen GK, Henriksen FW, Hancke S. Endoscopic ultrasonography with guided fine needle aspiration biopsy in pancreatic disease. Gastrointest Endosc. 1992 Mar-Apr;38(2):172-3. — View Citation
Wang Y, Chen Q, Wang J, Wu X, Duan Y, Yin P, Guo Q, Hou W, Cheng B. Comparison of modified wet suction technique and dry suction technique in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for solid lesions: study protocol for a randomized controlled trial. Trials. 2018 Jan 17;19(1):45. doi: 10.1186/s13063-017-2380-y. — View Citation
Wani S, Early D, Kunkel J, Leathersich A, Hovis CE, Hollander TG, Kohlmeier C, Zelenka C, Azar R, Edmundowicz S, Collins B, Liu J, Hall M, Mullady D. Diagnostic yield of malignancy during EUS-guided FNA of solid lesions with and without a stylet: a prospective, single blind, randomized, controlled trial. Gastrointest Endosc. 2012 Aug;76(2):328-35. doi: 10.1016/j.gie.2012.03.1395. Epub 2012 Jun 12. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare the diagnostic yield | compare the diagnostic yield between two EUS needles | 2 years | |
Secondary | extra passes with each needle | number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry | 2 years | |
Secondary | perform immunohistochemistry | need to perform immunohistochemistry to reach the result | 2 years | |
Secondary | adverse event rate | to assess the adverse event rate | 2 years |
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