Comparison of Two Needles (19G Flex Versus 22G Standard) for Pancreatic Solid Tumors Diagnosis
NCT ID: NCT02078232
Last Updated: 2017-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2013-04-30
2017-01-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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19G flex needle puncture
puncture of head of pancreas
puncture of head of pancreas
puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control.
randomization: puncture with either 22G needle or 19G flex needle
22G needle puncture
puncture of head of pancreas
puncture of head of pancreas
puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control.
randomization: puncture with either 22G needle or 19G flex needle
Interventions
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puncture of head of pancreas
puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control.
randomization: puncture with either 22G needle or 19G flex needle
puncture of head of pancreas
puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control.
randomization: puncture with either 22G needle or 19G flex needle
Eligibility Criteria
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Inclusion Criteria
* patient who understands the study procedures, risks and voluntarily agrees to participate by giving written informed consent
Exclusion Criteria
* patient mentally or legally incapacitated
* patient with contraindications to the achievement of upper gastrointestinal endoscopy
* patient with haemorrhagic disease, disorder of hemostasis and coagulation (TP\<60%, TCA\>40sec and platelets \<60000/mm3)
* patient with anticoagulant or antiaggregating treatment that could not be stopped for the endoscopic procedure
* patient with pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging)
* patient pregnant or lactating women
18 Years
ALL
No
Sponsors
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French Society of Digestive Endoscopy
OTHER
Responsible Party
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Christian BOUSTIERE
MD, Head of Endoscopy Department, Hôpital Saint Joseph, Marseille
Principal Investigators
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CHRISTIAN BOUSTIERE, MD
Role: PRINCIPAL_INVESTIGATOR
FRENCH SDE
Locations
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Hopital Saint Joseph
Marseille, , France
Countries
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References
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Jenssen C, Dietrich CF. Endoscopic ultrasound-guided fine-needle aspiration biopsy and trucut biopsy in gastroenterology - An overview. Best Pract Res Clin Gastroenterol. 2009;23(5):743-59. doi: 10.1016/j.bpg.2009.05.006.
Takemoto T, Aibe T, Fuji T, Okita K. Endoscopic ultrasonography. Clin Gastroenterol. 1986 Apr;15(2):305-19.
Erickson RA. EUS-guided FNA. Gastrointest Endosc. 2004 Aug;60(2):267-79. doi: 10.1016/s0016-5107(04)01529-9. No abstract available.
Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.
Song TJ, Kim JH, Lee SS, Eum JB, Moon SH, Park DY, Seo DW, Lee SK, Jang SJ, Yun SC, Kim MH. The prospective randomized, controlled trial of endoscopic ultrasound-guided fine-needle aspiration using 22G and 19G aspiration needles for solid pancreatic or peripancreatic masses. Am J Gastroenterol. 2010 Aug;105(8):1739-45. doi: 10.1038/ajg.2010.108. Epub 2010 Mar 9.
Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy; Lichtenstein DR, Jagannath S, Baron TH, Anderson MA, Banerjee S, Dominitz JA, Fanelli RD, Gan SI, Harrison ME, Ikenberry SO, Shen B, Stewart L, Khan K, Vargo JJ. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008 Nov;68(5):815-26. doi: 10.1016/j.gie.2008.09.029. No abstract available.
Adler DG, Jacobson BC, Davila RE, Hirota WK, Leighton JA, Qureshi WA, Rajan E, Zuckerman MJ, Fanelli RD, Baron TH, Faigel DO; ASGE. ASGE guideline: complications of EUS. Gastrointest Endosc. 2005 Jan;61(1):8-12. doi: 10.1016/s0016-5107(04)02393-4.
Al-Haddad M, Wallace MB, Woodward TA, Gross SA, Hodgens CM, Toton RD, Raimondo M. The safety of fine-needle aspiration guided by endoscopic ultrasound: a prospective study. Endoscopy. 2008 Mar;40(3):204-8. doi: 10.1055/s-2007-995336. Epub 2007 Dec 4.
Carrara S, Arcidiacono PG, Mezzi G, Petrone MC, Boemo C, Testoni PA. Pancreatic endoscopic ultrasound-guided fine needle aspiration: complication rate and clinical course in a single centre. Dig Liver Dis. 2010 Jul;42(7):520-3. doi: 10.1016/j.dld.2009.10.002. Epub 2009 Dec 1.
Boustiere C, Veitch A, Vanbiervliet G, Bulois P, Deprez P, Laquiere A, Laugier R, Lesur G, Mosler P, Nalet B, Napoleon B, Rembacken B, Ajzenberg N, Collet JP, Baron T, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Endoscopy and antiplatelet agents. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2011 May;43(5):445-61. doi: 10.1055/s-0030-1256317. Epub 2011 May 4.
Fayers PM, Machin D. Sample size: how many patients are necessary? Br J Cancer. 1995 Jul;72(1):1-9. doi: 10.1038/bjc.1995.268.
Laquiere A, Lefort C, Maire F, Aubert A, Gincul R, Prat F, Grandval P, Croizet O, Boulant J, Vanbiervliet G, Penaranda G, Lecomte L, Napoleon B, Boustiere C. 19 G nitinol needle versus 22 G needle for transduodenal endoscopic ultrasound-guided sampling of pancreatic solid masses: a randomized study. Endoscopy. 2019 May;51(5):436-443. doi: 10.1055/a-0757-7714. Epub 2018 Nov 19.
Other Identifiers
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SFED N°98
Identifier Type: -
Identifier Source: org_study_id
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