Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis

NCT ID: NCT03753815

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-22

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autoimmune Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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19G FNA needle

Patients referred for EUS-guided tissue acquisition of AIP

Group Type ACTIVE_COMPARATOR

19G FNA needle

Intervention Type DEVICE

Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle

20G FNB needle

Patients referred for EUS-guided tissue acquisition of AIP

Group Type ACTIVE_COMPARATOR

20G FNB needle

Intervention Type DEVICE

Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle

Interventions

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19G FNA needle

Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle

Intervention Type DEVICE

20G FNB needle

Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle

Intervention Type DEVICE

Other Intervention Names

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19G Echotip Ultra Fine Needle Aspiration (FNA) device 20G Echotip ProCore Fine Needle Biopsy (FNB) device

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aiming Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospitalollege Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Aiming Yang, M.D.

Role: CONTACT

+86-010-69151593

Yunlu Feng, M.D.

Role: CONTACT

+86-010-69151591

Facility Contacts

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Aiming Yang, M.D.

Role: primary

+86-10-69151593

Yunlu Feng, M.D.

Role: backup

+86-10-69151591

Other Identifiers

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ZS-1767

Identifier Type: -

Identifier Source: org_study_id

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