Back to resultsDiagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis
Primary Purpose
Autoimmune Pancreatitis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
19G FNA needle
20G FNB needle
Sponsored by
About this trial
This is an interventional diagnostic trial for Autoimmune Pancreatitis
Eligibility Criteria
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
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
19G FNA needle
20G FNB needle
Arm Description
Patients referred for EUS-guided tissue acquisition of AIP
Patients referred for EUS-guided tissue acquisition of AIP
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Technical success
tissue acquisition
Quality of the tissue sample
Quality, defined as; presence of core tissue
Quantity of the tissue sample
Quantity, defined as; presence of remnant material after diagnosis was obtained and sufficiency for advanced diagnostic processing
Diagnostic yield of the first needle pass
Adverse events
Safety
Full Information
NCT ID
NCT03753815
First Posted
November 22, 2018
Last Updated
April 28, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03753815
Brief Title
Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 22, 2018 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Pancreatitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
19G FNA needle
Arm Type
Active Comparator
Arm Description
Patients referred for EUS-guided tissue acquisition of AIP
Arm Title
20G FNB needle
Arm Type
Active Comparator
Arm Description
Patients referred for EUS-guided tissue acquisition of AIP
Intervention Type
Device
Intervention Name(s)
19G FNA needle
Other Intervention Name(s)
19G Echotip Ultra Fine Needle Aspiration (FNA) device
Intervention Description
Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle
Intervention Type
Device
Intervention Name(s)
20G FNB needle
Other Intervention Name(s)
20G Echotip ProCore Fine Needle Biopsy (FNB) device
Intervention Description
Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle
Primary Outcome Measure Information:
Title
Diagnostic accuracy (compared to the gold standard diagnosis)
Description
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
Secondary Outcome Measure Information:
Title
Technical success
Description
tissue acquisition
Time Frame
24 months
Title
Quality of the tissue sample
Description
Quality, defined as; presence of core tissue
Time Frame
within 2 weeks after the EUS procedure and after 24 months
Title
Quantity of the tissue sample
Description
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
Title
Diagnostic yield of the first needle pass
Time Frame
within 2 weeks after the EUS procedure and after 24 months
Title
Adverse events
Description
Safety
Time Frame
first 24 hours until - 24 months after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aiming Yang, M.D.
Phone
+86-010-69151593
Email
yangaiming@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yunlu Feng, M.D.
Phone
+86-010-69151591
Email
yunluf@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiming Yang, M.D.
Organizational Affiliation
Peking Union Medical College Hospitalollege Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiming Yang, M.D.
Phone
+86-10-69151593
Email
yangaiming@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Yunlu Feng, M.D.
Phone
+86-10-69151591
Email
yunluf@icloud.com
12. IPD Sharing Statement
Learn more about this trial
Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis
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