Autoimmune PancreatitisNCT03753815
Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis
A study testing 19G FNA needle and 20G FNB needle in people with Autoimmune Pancreatitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Autoimmune Pancreatitis
- What is being tested?
- 19G FNA needle and 20G FNB needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2018to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for EUS-guided tissue acquisition because of clinical suspicion of AIP
- Age > 18 years
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Aiming Yang, M.D., +86-10-69151593, yangaiming@medmail.com.cn
Yunlu Feng, M.D., +86-10-69151591, yunluf@icloud.com
About this study
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.
Read the 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.
- Conditions
- Autoimmune Pancreatitis
- Being tested
- 19G FNA needle, 20G FNB needle
- Medical subject headings
- Autoimmune Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19G FNA needleDevice
Also called 19G Echotip Ultra Fine Needle Aspiration (FNA) device
Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle
20G FNB needleDevice
Also called 20G Echotip ProCore Fine Needle Biopsy (FNB) device
Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle
| Study group | Role | What they receive |
|---|---|---|
| 19G FNA needle | Active comparator | Patients referred for EUS-guided tissue acquisition of AIP Receives: Device: 19G FNA needle |
| 20G FNB needle | Active comparator | Patients referred for EUS-guided tissue acquisition of AIP Receives: Device: 20G FNB needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (5)
Technical success
tissue acquisition
Measured: 24 months
Quality of the tissue sample
Quality, defined as; presence of core tissue
Measured: within 2 weeks after the EUS procedure and after 24 months
Quantity of the tissue sample
Quantity, defined as; presence of remnant material after diagnosis was obtained and sufficiency for advanced diagnostic processing
Measured: within 2 weeks after the EUS procedure and after 24 months
Diagnostic yield of the first needle pass
Measured: within 2 weeks after the EUS procedure and after 24 months
Adverse events
Safety
Measured: first 24 hours until - 24 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start22 Nov 2018
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune PancreatitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aiming Yang, M.D., Principal investigator, Peking Union Medical College Hospitalollege Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753815
- Sponsor's protocol ID
- ZS-1767
- Status last verified
- Apr 2021
- First submitted
- 22 Nov 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiao Y, Chang X, Feng Y, Zhang S, Jiang Q, Guo T, Wang Q, Wu D, Wu X, Wu Y, Wang H, Shi W, Yang A. Comparison of 19-gauge aspiration needles versus 20-gauge forward-bevel needles for diagnosing autoimmune pancreatitis: a single-centre randomised controlled trial. BMC Gastroenterol. 2026 Apr 21;26(1):342. doi: 10.1186/s12876-026-04811-8.
PubMed 42014994
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03753815
- Acronym / sponsor ID
- ZS-1767
- Conditions
- Autoimmune Pancreatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 19G FNA needle | Active comparator | Device: 19G FNA needlePatients referred for EUS-guided tissue acquisition of AIP |
| 20G FNB needle | Active comparator | Device: 20G FNB needlePatients referred for EUS-guided tissue acquisition of AIP |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred for EUS-guided tissue acquisition because of clinical suspicion of AIP
- Age > 18 years
- Written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 19G FNA needleAlso: 19G Echotip Ultra Fine Needle Aspiration (FNA) devicePuncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle | Device | 19G FNA needle |
| 20G FNB needleAlso: 20G Echotip ProCore Fine Needle Biopsy (FNB) devicePuncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle | Device | 20G FNB needle |
Primary outcome
Diagnostic accuracy (compared to the gold standard diagnosis)
Time frame: 24 months
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
5 secondary outcomes
Technical success
Time frame: 24 months
Quality of the tissue sample
Time frame: within 2 weeks after the EUS procedure and after 24 months
Quantity of the tissue sample
Time frame: within 2 weeks after the EUS procedure and after 24 months
Diagnostic yield of the first needle pass
Time frame: within 2 weeks after the EUS procedure and after 24 months
Adverse events
Time frame: first 24 hours until - 24 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 42014994Jiao Y, Chang X, Feng Y, Zhang S, Jiang Q, Guo T, Wang Q, Wu D, Wu X, Wu Y, Wang H, Shi W, Yang A. Comparison of 19-gauge aspiration needles versus 20-gauge forward-bevel needles for diagnosing autoimmune pancreatitis: a single-centre randomised controlled trial. BMC Gastroenterol. 2026 Apr 21;26(1):342. doi: 10.1186/s12876-026-04811-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiming Yang, M.D. principal investigator
Peking Union Medical College Hospitalollege Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 19G FNA needle and 20G FNB needle in people with Autoimmune Pancreatitis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aiming Yang, M.D. (+86-010-69151593, yangaiming@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (compared to the gold standard diagnosis) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.