NCT02078232

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2017

Completed
Last Updated

April 20, 2017

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

February 26, 2014

Last Update Submit

April 19, 2017

Conditions

Adenocarcinoma of Head of Pancreas

Keywords

fine needle aspiration under ultrasound endoscopysolid pancreatic tumorshead of pancreas19G Flex needle22G standard needle

Outcome Measures

Primary Outcomes (1)

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

    accuracy and diagnostic gain of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic tumors of the head of pancreas: comparison between 19G Flex and 22G standard needles punctures.

    10 days

Secondary Outcomes (2)

  • morbidity

    2 minutes, up to day 30

  • quality of histology

    10 days

Study Arms (2)

19G flex needle puncture

EXPERIMENTAL

puncture of head of pancreas

Device: puncture of head of pancreas

22G needle puncture

ACTIVE COMPARATOR

puncture of head of pancreas

Device: puncture of head of pancreas

Interventions

puncture of head of pancreasDEVICE

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

19G flex needle puncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with solid tumor of pancreas who has to receive a biopsy under endoscopic ultrasound (EUS)
  • patient who understands the study procedures, risks and voluntarily agrees to participate by giving written informed consent

You may not qualify if:

  • patient who participates in an other study
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Joseph

Marseille, 13008, France

Location

Related Publications (12)

  • 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.

    PMID: 19744637BACKGROUND

  • Takemoto T, Aibe T, Fuji T, Okita K. Endoscopic ultrasonography. Clin Gastroenterol. 1986 Apr;15(2):305-19.

    PMID: 3524913BACKGROUND

  • Erickson RA. EUS-guided FNA. Gastrointest Endosc. 2004 Aug;60(2):267-79. doi: 10.1016/s0016-5107(04)01529-9. No abstract available.

    PMID: 15278063BACKGROUND

  • 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.

    PMID: 22248600BACKGROUND

  • 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.

    PMID: 20216532BACKGROUND

  • 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.

    PMID: 18984096BACKGROUND

  • 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.

    PMID: 15672049BACKGROUND

  • 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.

    PMID: 18058615BACKGROUND

  • 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.

    PMID: 19955025BACKGROUND

  • 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.

    PMID: 21547880BACKGROUND

  • 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.

    PMID: 7599035BACKGROUND

  • 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.

    PMID: 30453379DERIVED

Study Officials

  • CHRISTIAN BOUSTIERE, MD

    FRENCH SDE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Head of Endoscopy Department, Hôpital Saint Joseph, Marseille

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 5, 2014

Study Start

April 1, 2013

Primary Completion

July 6, 2016

Study Completion

January 23, 2017

Last Updated

April 20, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)