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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 19G FNA needle | Active Comparator | Patients referred for EUS-guided tissue acquisition of AIP |
|
| 20G FNB needle | Active Comparator | Patients referred for EUS-guided tissue acquisition of AIP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 19G FNA needle | Device | Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiming Yang, M.D. | Contact | +86-010-69151593 | yangaiming@medmail.com.cn | |
| Yunlu Feng, M.D. | Contact | +86-010-69151591 | yunluf@icloud.com |
| Name | Affiliation | Role |
|---|---|---|
| Aiming Yang, M.D. | Peking Union Medical College Hospitalollege Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42014994 | Derived | Jiao Y, Chang X, Feng Y, Zhang S, Jiang Q, Guo T, Wang Q, Wu D, Wu X, Wu Y, Wang H, Shi W, Yang A. Comparison of 19-gauge aspiration needles versus 20-gauge forward-bevel needles for diagnosing autoimmune pancreatitis: a single-centre randomised controlled trial. BMC Gastroenterol. 2026 Apr 21;26(1):342. doi: 10.1186/s12876-026-04811-8. |
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| ID | Term |
|---|---|
| D000081012 | Autoimmune Pancreatitis |
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| 20G FNB needle | Device | Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle |
|
|
| 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 |
| D001327 |
| Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |