Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis

Autoimmune Pancreatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03753815
• Other study ID #: ZS-1767
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2018
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: Peking Union Medical College Hospital
• Contact: Aiming Yang, M.D.
• Phone: +86-010-69151593
• Email: yangaiming[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Pancreatitis
• Pancreatitis

Intervention

Device:
• 19G FNA needle
Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle
• 20G FNB needle
Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Technical success	tissue acquisition	24 months
Secondary	Quality of the tissue sample	Quality, defined as; presence of core tissue	within 2 weeks after the EUS procedure and after 24 months
Secondary	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
Secondary	Diagnostic yield of the first needle pass		within 2 weeks after the EUS procedure and after 24 months
Secondary	Adverse events	Safety	first 24 hours until - 24 months after procedure