Autoimmune Pancreatitis
Conditions
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.
Interventions
DEVICE19G FNA needle
Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle
DEVICE20G FNB needle
Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 24 months | tissue acquisition |
| Quality of the tissue sample | within 2 weeks after the EUS procedure and after 24 months | Quality, defined as; presence of core tissue |
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactAiming Yang, M.D.
Backup ContactYunlu Feng, M.D.
Outcome results
None listed