Status:
COMPLETED
Prospective Study on the Role of Eus-fnb in the Diagnosis of Autoimmune Pancreatitis
Lead Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Conditions:
Autoimmune Pancreatitis
Eligibility:
All Genders
18+ years
Brief Summary
According to the reported histological procurement yield of the end-cutting needles, the investigators supposed that the use of EUS-FNB in probable AIP patients, generally aimed only to rule-out malig...
Detailed Description
The primary aim is to evaluate the capability of EUS-FNB to enhance diagnostic levels of AIP, that means to obtain definitive diagnosis of type 1 and type 2 AIP. Secondary aims are to evaluate: Safety...
Eligibility Criteria
Inclusion
- Consecutive patients ≥ 18 years old;
- Suspected focal or diffuse AIP, according to ICDC:
- Probable type 1 AIP Probable type 2 AIP NOS-AIP
- • provision of written consent to participate in the study.
Exclusion
- Previous diagnosis of AIP
- Definitive type 1 AIP
- Steroid administration within 3 months before the EUS-FNB
- Coagulation disorders
- Pregnant and lactating women
- Unable to give informed consent
Key Trial Info
Start Date :
May 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04397731
Start Date
May 1 2020
End Date
June 1 2023
Last Update
February 7 2025
Active Locations (2)
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1
Azienda Ospedaliera Integrata Verona
Verona, Italy, 37134
2
Tsukasa Ikeura
Osaka, Japan