An interventional study of 19G FNA needle and 20G FNB needle in Autoimmune Pancreatitis, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Diagnostic
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.
751 studies on the registry are indexed under Pancreatitis; 180 are open to participants now.
This study's planned enrollment of 46 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.
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Exclusion Criteria:
Patients referred for EUS-guided tissue acquisition of AIP
Device: 19G FNA needle
Patients referred for EUS-guided tissue acquisition of AIP
Device: 20G FNB needle
Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle
Also known as: 19G Echotip Ultra Fine Needle Aspiration (FNA) device
Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle
Also known as: 20G Echotip ProCore Fine Needle Biopsy (FNB) device
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
Time frame: 24 months
Technical success
tissue acquisition
Time frame: 24 months
Quality of the tissue sample
Quality, defined as; presence of core tissue
Time frame: 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
Time frame: within 2 weeks after the EUS procedure and after 24 months
Diagnostic yield of the first needle pass
Time frame: within 2 weeks after the EUS procedure and after 24 months
Adverse events
Safety
Time frame: first 24 hours until - 24 months after procedure
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital