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Conventional Versus Elastography Targeted Endoscopic Ultrasound Fine Needle Aspiration of Solid Pancreatic Lesions

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ClinicalTrials.gov Identifier: NCT03210948
Recruitment Status : Not yet recruiting
First Posted : July 7, 2017
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Antonio Facciorusso, Ospedali Riuniti di Foggia

Brief Summary:

Diagnostic assessment of solid pancreatic lesions may represent a real challenge in the clinical practice, even with the aid of tissue sampling by means of endoscopic ultrasound (EUS) fine needle aspiration (FNA).

Aim of this randomized controlled trial (RCT) is to establish the diagnostic accuracy, sensitivity, and specificity of real time elastography (RTE)-guided EUS-FNA as compared to conventional EUS-FNA in a series of patients with solid pancreatic masses.

Eligible will be patients with solid pancreatic masses detected at abdominal imaging (ultrasound, CT-scan or MRI).

In the treatment arm, RTE assessment of pancreatic masses will be performed using a last generation ultrasound machine, and all suspicious areas at elastography (i.e. those appearing in dark blue color as a consequence of higher cellularity of tumoral tissue) will be recorded and stored in our database. A 25 G needle will be then inserted into the most suspicious part ("dark blue") of the lesion and immediately after the procedure the stylet will be removed. At the end of the procedure, the needle will be retracted and the samples will be prepared for cytological examination.

Primary endpoint will be diagnostic yield of the procedure. Secondary endpoints the diagnostic sensitivity, specificity, number of passes needed to achieve an adequate sample and safety It will be planned to enroll 142 patients (71 per arms) within 1 year. A minimum follow up of 6 months from the last patient unsuitable to surgery will be required.


Condition or disease Intervention/treatment Phase
Pancreas Cancer Device: RTE-guided EUS-FNA Device: Conventional EUS-FNA Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Conventional Versus Elastography Targeted Endoscopic Ultrasound Fine Needle Aspiration of Solid Pancreatic Lesions: a Randomized Controlled Trial
Estimated Study Start Date : January 23, 2019
Estimated Primary Completion Date : February 20, 2019
Estimated Study Completion Date : February 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RTE-guided EUS-FNA
The needle will be then inserted into the most suspicious part ("dark blue") of the lesion as assessed at real time elastography.
Device: RTE-guided EUS-FNA
Fine needle aspiration with 25 gauge needle under RTE-guidance

Active Comparator: Conventional EUS-FNA
A 25 G needle with a central stylet to protect the aspiration channel of the needle will be introduced though the endoscope's working channel.
Device: Conventional EUS-FNA
Fine needle aspiration with no RTE guidance




Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: 12 months ]
    Proportion of correctly classified subjects (true positives+true negatives) among all subjects (true positives+true negatives+false positives+false negatives)


Secondary Outcome Measures :
  1. Diagnostic sensitivity [ Time Frame: 12 months ]
    Proportion of subjects with the disease with positive test result in a total group of subjects with the disease

  2. Diagnostic specificity [ Time Frame: 12 months ]
    Proportion of subjects without the disease with negative test result in total of subjects without disease

  3. Number of passes needed to achieve an adequate sample [ Time Frame: 1 day ]
    Number of needle injections into the lesion needed to obtain an adequate and diagnostic sample

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 week ]
    Side effects



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with solid pancreatic masses detected at abdominal imaging (ultrasound, CT-scan or MRI).

Exclusion Criteria:

  • Age under 18 years
  • Cystic pancreatic lesions
  • Lesions < 1 cm
  • History of previous gastrectomy
  • Patients with severe coagulopathy or under anticoagulant/antiaggregant therapy which could not be suspended
  • Refusal to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210948


Contacts
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Contact: Antonio Facciorusso, MD +39 0881732015 antonio.facciorusso@virgilio.it
Contact: Nicola Muscatiello, MD +39 0881733848 nicomuscatiello@gmail.com

Locations
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Italy
Ospedali Riuniti Foggia Not yet recruiting
Foggia, Italy, 71122
Contact: Antonio Facciorusso, MD       antonio.facciorusso@virgilio.it   
Sponsors and Collaborators
Ospedali Riuniti di Foggia
Investigators
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Study Director: Antonio Facciorusso, MD Ospedali Riuniti di Foggia

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Responsible Party: Antonio Facciorusso, MD, Ospedali Riuniti di Foggia
ClinicalTrials.gov Identifier: NCT03210948     History of Changes
Other Study ID Numbers: EUS01
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases