Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis

Study Overview
=================
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.

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

Conditions
-----------------
Autoimmune Pancreatitis

Intervention / Treatment
-----------------
* Device: 19G FNA needle
* Device: 20G FNB needle


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 19G FNA needle<br>Patients referred for EUS-guided tissue acquisition of AIP | Device: 19G FNA needle<br>* Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle<br>* Other names: 19G Echotip Ultra Fine Needle Aspiration (FNA) device;|
| Active Comparator: 20G FNB needle<br>Patients referred for EUS-guided tissue acquisition of AIP | Device: 20G FNB needle<br>* Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle<br>* Other names: 20G Echotip ProCore Fine Needle Biopsy (FNB) device;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy (compared to the gold standard diagnosis) | 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | tissue acquisition | 24 months | 
| Quality of the tissue sample | Quality, defined as; presence of core tissue | within 2 weeks after the EUS procedure and after 24 months | 
| Quantity of the tissue sample | Quantity, defined as; presence of remnant material after diagnosis was obtained and sufficiency for advanced diagnostic processing | within 2 weeks after the EUS procedure and after 24 months | 
| Diagnostic yield of the first needle pass |  | within 2 weeks after the EUS procedure and after 24 months | 
| Adverse events | Safety | first 24 hours until - 24 months after procedure |