Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis

Not Applicable

• Conditions: Autoimmune Pancreatitis
• Interventions: Device: 20G FNB needle; Device: 19G FNA needle

• Registration Number: NCT03753815
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2018-11-22
• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-11-23
• Study First Posted: 2018-11-27
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-30
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20G FNB needle	20G FNB needle	Patients referred for EUS-guided tissue acquisition of AIP
19G FNA needle	19G FNA needle	Patients referred for EUS-guided tissue acquisition of AIP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Quality of the tissue sample	within 2 weeks after the EUS procedure and after 24 months	Quality, defined as; presence of core tissue
Diagnostic yield of the first needle pass	within 2 weeks after the EUS procedure and after 24 months
Adverse events	first 24 hours until - 24 months after procedure	Safety
Technical success	24 months	tissue acquisition
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China