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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autoimmune Pancreatitis
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy (compared to the gold standard diagnosis)
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Diagnostic accuracy (compared to the gold standard diagnosis)
Time Frame: 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 Outcomes
- Quality of the tissue sample(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(first 24 hours until - 24 months after procedure)
- Technical success(24 months)
- Quantity of the tissue sample(within 2 weeks after the EUS procedure and after 24 months)