Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Autoimmune Pancreatitis

Treatments: Device: 19G FNA needle; Device: 20G FNB needle

Study type: Interventional

Funder types: Other

Identifiers

NCT03753815

ZS-1767

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

46 participants in 2 patient groups

19G FNA needle

Active Comparator group

Description:

Patients referred for EUS-guided tissue acquisition of AIP

Treatment:

Device: 19G FNA needle

20G FNB needle

Active Comparator group

Description:

Patients referred for EUS-guided tissue acquisition of AIP

Treatment:

Device: 20G FNB needle