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Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03753815
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
36.3
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 19G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device for the diagnosis of autoimmune pancreatitis.

Condition or Disease Intervention/Treatment Phase
  • Device: 19G FNA needle
  • Device: 20G FNB needle
 N/A

Detailed Description

Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to diagnose autoimmune pancreatitis (AIP) and exclude malignancy. During Endoscopic Ultrasound (EUS), tissue samples can be obtained for pathological evaluation with different devices. Previous studies suggest 19-gauge fine needle aspiration (FNA) needle provides a reliable specimen for diagnosis of AIP. However tissue architecture and cell morphology are essential for accurate pathological assessment. Therefore, pathologists generally prefer a histological specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen, which may lead to better diagnostic performance. However, the superiority of histology over cytology in EUS-guided tissue sampling for diagnosis of AIP has not been proven yet. In this study, we aim to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 19G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device for the diagnosis of autoimmune pancreatitis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
A Randomized Trial Comparing a 19-gauge EUS Fine-needle Aspiration Device With a 20-gauge Fine-needle Biopsy Device for the Diagnosis of Autoimmune Pancreatitis
Actual Study Start Date :
Nov 22, 2018
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 19G FNA needle

Patients referred for EUS-guided tissue acquisition of AIP

Device: 19G FNA needle
Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle
Other Names:
  • 19G Echotip Ultra Fine Needle Aspiration (FNA) device

    		•
    Active Comparator: 20G FNB needle

    Patients referred for EUS-guided tissue acquisition of AIP

    Device: 20G FNB needle
    Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle
    Other Names:
  • 20G Echotip ProCore Fine Needle Biopsy (FNB) device

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic accuracy (compared to the gold standard diagnosis) [24 months]

      Gold standard diagnosis is defined as: based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 12 months

    Secondary Outcome Measures

    1. Technical success [24 months]

      tissue acquisition

    2. Quality of the tissue sample [within 2 weeks after the EUS procedure and after 24 months]

      Quality, defined as; presence of core tissue

    3. Quantity of the tissue sample [within 2 weeks after the EUS procedure and after 24 months]

      Quantity, defined as; presence of remnant material after diagnosis was obtained and sufficiency for advanced diagnostic processing

    4. Diagnostic yield of the first needle pass [within 2 weeks after the EUS procedure and after 24 months]

    5. Adverse events [first 24 hours until - 24 months after procedure]

      Safety

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients referred for EUS-guided tissue acquisition because of clinical suspicion of AIP

    • Age > 18 years

    • Written informed consent

    Exclusion Criteria:

    • Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)

    • Use of anticoagulants that cannot be discontinued in order to guarantee an INR below 1.5

    • Previous inclusion in the current study

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Principal Investigator: Aiming Yang, M.D., Peking Union Medical College Hospitalollege Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT03753815
    Other Study ID Numbers:
    • ZS-1767
    First Posted:
    Nov 27, 2018
    Last Update Posted:
    Apr 30, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatitis
    Autoimmune Pancreatitis

    Study Results

    No Results Posted as of Apr 30, 2021