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Comparison of Two Needles (19G Flex Versus 22G Standard) for Pancreatic Solid Tumors Diagnosis

Information source: French Society of Digestive Endoscopy
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adenocarcinoma of Head of Pancreas

Intervention: puncture of head of pancreas (Device); puncture of head of pancreas (Device)

Phase: Phase 3

Status: Recruiting

Sponsored by: French Society of Digestive Endoscopy

Official(s) and/or principal investigator(s):
CHRISTIAN BOUSTIERE, MD, Principal Investigator, Affiliation: FRENCH SDE

Overall contact:
Christian Boustière, MD, PI, Phone: 33 491808207, Email: boustiere@orange.fr

Summary

The purpose of this study is to compare the diagnostic gain between 22G standard needle vs 19G Flex needles transduodenal punctures of masses of the pancreatic head.

Clinical Details

Official title: Randomized, Comparative Study of 19G Flex Versus 22G Standard Needles for Pancreatic Solid Tumors Diagnosis.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: accuracy of 19G Flex Expect needle in the histological diagnosis of pancreatic solid tumors of the head of pancreas

Secondary outcome:

morbidity

quality of histology

Detailed description: The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS-FNA)

for the diagnosis of solid pancreatic masses is about 70 - 80 % with the 22G standard

needle. Pancreatic adenocarcinoma is known to have a severe prognosis and a low rate of survival even after curative surgery. The study of pancreatic solid tumors is one the main diagnostic problem present in the investigators daily practice. In most of non operated patients, EUS-FNA is the sole possibility to confirm the diagnosis of malignancy which is required to initiate chemotherapy and/or radiotherapy. To improve the performances of the EUS-FNA, new needles are now disposable either with a cutting window design (EchoTip

ProCore-COOK Medical) or flexible 19G needle (19G Expect Flex - Boston-Scientific). The goal

is to obtain more tissue material with the possibility of a histologic study without increasing the risk of the puncture which is very low (complications rate < 1%). The problem concerns the lesion of the head of the pancreas requiring a trans-duodenal access for the puncture . In this position, the needle is very difficult to push out the operator channel and, in some cases, the puncture is quite impossible with stiff needles as "ProCore" or standard 19G. Thus, the interest of flexible 19G needle is to be used in difficult technical cases as transduodenal access for head pancreatic tumors, with a good safety and more efficacy than 22G needles.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: solid tumor of pancreas to receive a biopsy under endoscopic ultrasound (EUS) patient understands the study procedures, risks and voluntarily agrees to participate by giving written informed consent Exclusion Criteria: patient participates in an other study patient mentally or legally incapacitated contraindications to the achievement of upper gastrointestinal endoscopy 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 pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging) pregnant or lactating women

Locations and Contacts

Christian Boustière, MD, PI, Phone: 33 491808207, Email: boustiere@orange.fr

Hopital Saint Joseph, Marseille 13008, France; Recruiting
Christian Boustière, MD, Phone: 33 491808207, Email: boustiere@orange.fr
Christian Boustière, MD, Principal Investigator
Additional Information

Related publications:

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. Review.

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. Review.

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 do H, 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.

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. Erratum in: Gastrointest Endosc. 2005 Mar;61(3):502.

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. 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.

Boustière 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. Review.

Starting date: April 2013
Last updated: March 3, 2014

Page last updated: August 23, 2015

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