Clinical trial NCT03753815: Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autoimmune Pancreatitis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy (compared to the gold standard diagnosis)
timeFrame: 24 months
Secondary outcomes:
measure: Technical success
timeFrame: 24 months
measure: Quality of the tissue sample
timeFrame: within 2 weeks after the EUS procedure and after 24 months
measure: Quantity of the tissue sample
timeFrame: within 2 weeks after the EUS procedure and after 24 months
measure: Diagnostic yield of the first needle pass
timeFrame: within 2 weeks after the EUS procedure and after 24 months
measure: Adverse events
timeFrame: first 24 hours until - 24 months after procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospitalollege Hospital
name: Aiming Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: