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Adenocarcinoma of Head of PancreasEASYFLEXNCT02078232

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

A study testing puncture of head of pancreas in people with Adenocarcinoma of Head of Pancreas, run by French Society of Digestive Endoscopy at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenocarcinoma of Head of Pancreas
What is being tested?
puncture of head of pancreas
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteFrance
Study dates
Apr 2013to 23 Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital Saint Joseph

    Marseille, 13008

Other trials in France

About this study

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

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.

Read the 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.

Being tested
puncture of head of pancreas
Keywords
fine needle aspiration under ultrasound endoscopy, solid pancreatic tumors, head of pancreas, 19G Flex needle, 22G standard needle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

Study groups in NCT02078232
Study groupRoleWhat they receive
19G flex needle punctureExperimentalpuncture of head of pancreas
Receives: Device: puncture of head of pancreas
22G needle punctureActive comparatorpuncture of head of pancreas
Receives: Device: puncture of head of pancreas

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 10 days

Secondary outcomes (2)

  1. morbidity

    immediate per-procedure complications and delayed morbidity (up to day 30) side effects resulting of technical failure or dysfunction of the puncture ease of handling for the two needles (visual analogic scale)

    Measured: 2 minutes, up to day 30

  2. quality of histology

    quality of histological specimens obtained with the 2 types of needles (visual analogic scale)

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2014 (estimated)
  2. Study startApr 2013
  3. Primary completion6 Jul 2016
  4. Study completion23 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02078232
Sponsor's protocol ID
SFED N°98
Acronym
EASYFLEX
Status last verified
Nov 2016
First submitted
26 Feb 2014
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 19744637

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

    PubMed 3524913

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

    PubMed 15278063

  • 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.

    PubMed 22248600

  • 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.

    PubMed 20216532

  • 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.

    PubMed 18984096

  • 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.

    PubMed 15672049

  • 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.

    PubMed 18058615

  • 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.

    PubMed 19955025

  • 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.

    PubMed 21547880

  • 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.

    PubMed 7599035

  • 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.

    PubMed 30453379

Questions about this trial

What is this clinical trial studying?

A study testing puncture of head of pancreas in people with Adenocarcinoma of Head of Pancreas, run by French Society of Digestive Endoscopy at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

accuracy of 19G Flex Expect needle in the histological diagnosis of pancreatic solid tumors of the head of pancreas (time frame: 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02078232, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.

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