EUS-FNB for AIP Study

JRCT ID: jRCTs042180092

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Autoimmune pancreatitis
• Date of first enrollment: 31/05/2017
• Target sample size: 50
• Study type: Interventional
• Intervention(s): A specific biopsy needle will be used in the tissue acquisition of the pancreas.

Outcome(s)

• Primary Outcome: Detection rate of pathological findings with meet level 1 of International consensus diagnostic criteria for autoimmune pancreatitis by EUS-FNB

Secondary Outcome

1)Detection rate of pathological findings which meet level 2 of International consensus diagnostic criteria (ICDC) by EUS-FNB
2)Detection rate of each pathological finding in ICDC by EUS-FNB
3)Contribution degree of EUS-FNB in the diagnosis of autoimmune pancreatitis
4)Complications of EUS-FNB

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1)Patients who meet image criteria of autoimmune pancreatitis (AIP) on International consensus diagnostic criteria (ICDC) and have not treated before.
2)Patients between 20 and 85 years old at the time of enrollment.
3)Performance status of 0 to 1.
4)Preservation of main organ functions at the time of diagnosis.
5)Provision of written consent to participate in the study.

Exclude criteria

1)Steroid administration within 3 months before the initiation of treatment.
2)Poorly controlled infection (including active tuberculosis).
3)Serious drug allergy.
4)Difficult in observation of the course of endoscopy.
5)Malignant tumor.
6)Serious adverse events.
7)Pregnant and lactating women, women who are possibly pregnant, and women who might want to become pregnant.
8)Severe mental disorder
9)Judgement as being ineligible by the principal or subinvestigator.

Related Information

• Primary Sponsor: Ishikawa Takuya
• Source(s) of Monetary Support: Boston Scientific Japan K.K.
• Secondary ID(s): UMIN000026692