Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Pancreatitis
• Intervention / Treatment: Device: 19G FNA needle; Device: 20G FNB needle

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 Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aiming Yang, M.D.; Phone Number: +86-010-69151593; Email: yangaiming@medmail.com.cn
• Study Contact Backup: Name: Yunlu Feng, M.D.; Phone Number: +86-010-69151591; Email: yunluf@icloud.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Aiming Yang, M.D.; Phone Number: +86-10-69151593; Email: yangaiming@medmail.com.cn
      • Contact: Yunlu Feng, M.D.; Phone Number: +86-10-69151591; Email: yunluf@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Aiming Yang, M.D., Peking Union Medical College Hospitalollege Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2018
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 22, 2018
• First Submitted That Met QC Criteria: November 23, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Autoimmune Diseases; Pancreatic Diseases; Pancreatitis, Chronic; Pancreatitis; Autoimmune Pancreatitis
• Other Study ID Numbers: ZS-1767

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No