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
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
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 |
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