Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis
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
1 other identifier
interventional
46
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2018
CompletedStudy Start
First participant enrolled
November 22, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedApril 30, 2021
April 1, 2021
2.9 years
November 22, 2018
April 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Technical success
24 months
Quality of the tissue sample
within 2 weeks after the EUS procedure and after 24 months
Quantity of the tissue sample
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
first 24 hours until - 24 months after procedure
Study Arms (2)
19G FNA needle
ACTIVE COMPARATORPatients referred for EUS-guided tissue acquisition of AIP
20G FNB needle
ACTIVE COMPARATORPatients referred for EUS-guided tissue acquisition of AIP
Interventions
Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle
Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle
Eligibility Criteria
You may qualify if:
- Patients referred for EUS-guided tissue acquisition because of clinical suspicion of AIP
- Age \> 18 years
- Written informed consent
You may not qualify if:
- 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
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aiming Yang, M.D.
Peking Union Medical College Hospitalollege Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2018
First Posted
November 27, 2018
Study Start
November 22, 2018
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
April 30, 2021
Record last verified: 2021-04