Autoimmune PancreatitisBIO_AIPNCT04397731
Prospective Study on the Role of Eus-fnb in the Diagnosis of Autoimmune Pancreatitis
An observational study of Autoimmune Pancreatitis, run by Azienda Ospedaliera Universitaria Integrata Verona at 2 sites in 2 countries.
Trial 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 malignancy, could provide histological tissue samples useful in enhancing the diagnostic level reached without histology, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Pancreatitis
- How many people
- 52 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2020to 1 Jun 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected AIP who need histological sampling for diagnosis.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Role of Endoscopic Ultrasound-guided Fine-needle Biopsy in the Diagnosis of Autoimmune Pancreatitis
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 malignancy, could provide histological tissue samples useful in enhancing the diagnostic level reached without histology, or defining the type of AIP.
Read the 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 of EUS-FNB in this setting of patients; the possibility to obtain a definitive diagnosis in focal/segmental form of AIP (that are the most clinically relevant because of the mimicking of cancer); diagnostic yield of EUS-FNB in this patient population; the rate of pancreatic neoplasms mimicking AIP.
Consecutive patients ≥ 18 years old, with suspected focal or diffuse AIP, according to ICDC (probable type 1 AIP; probable type 2 AIP; NOS-AIP) with written consent to participate in the study will be enrolled.
Exclusion criteria include: previous diagnosis of AIP; definitive type 1 AIP; steroid administration within 3 months before the EUS-FNB; coagulation disorders; pregnancy and lactation; unability to give informed consent .
The histopathology of the preparations will be evaluated, according to the ICDC, including the LPSP findings and the IDCP findings and recording the absence or presence of specific criteria: Periductal lymphoplasmacytic infiltrate without GELs, Storiform fibrosis, Obliterative phlebitis >10 IgG4-positive cells per HPF; GEL of duct wall; Granulocytic and lympho- plasmacytic acinar infiltrate.
According to the current clinical practice, when the diagnosis of AIP is confirmed (and malignancy is ruled-out) patient will be treated with the standard therapy for AIP. Patients will be followed for 12 months, in order to exclude misdiagnosed malignancy, and to evaluate the clinical course of the disease (response to steroid therapy, relapses, changes in imaging findings or surgical pathology in resected patients).
The final diagnosis of AIP will be confirmed on surgical pathology (in resected patients) or when a compatible clinical course is observed during a follow-up of at least 1 year (significant improvement on imaging after steroid therapy, no appearance of metastasis or sign of infiltration).
The number of cases where EUS-FNB histology improves the diagnostic level will be summarized using absolute and relative frequencies. The 95% confidence interval of this proportion will also be computed. The number of adverse events, the number of cases where histological finding diagnostic of AIP are observed in focal/segmental form and the number of pancreatic neoplasm will be summarized using absolute and relative frequencies. Sensitivity, specificity, positive likelihood ratio (LR+), negative likelihood Ratio (LR-) and the ROC curve will be used to analyze the capability of EUS-FNB to obtain a definitive diagnosis of type 1 and 2 AIP.
- Conditions
- Autoimmune Pancreatitis
- Keywords
- ICDC criteria, AIP, HISTOLOGY IN AIP, EUS-FNB, Endoscopic fine needle biopsy
- Medical subject headings
- Autoimmune Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
For the primary aim, the endpoint is the percentage of cases where EUS-FNB histology improve the diagnostic level:
- from a probable AIP 1 to definitive AIP 1 (i.e., percentage of type 1 Level 1 H);
- from a probable AIP 2 to definitive AIP 2 (i.e., percentage of type 2 Level 1 H);
- from an AIP-NOS to AIP 1 or 2 (i.e., percentage of type 1 and 2, Level 1 H or Level 2 H).
Measured: 2 years
Secondary outcomes (4)
Safety of EUS-FNB in AIP patients: percentage of adverse events observed
The percentage of adverse events observed
Measured: 2 years
The possibility to obtain a definitive diagnosis in focal/segmental form of AIP (that are the most clinically relevant because of the mimicking of cancer).
The Percentage of cases where histological finding diagnostic of AIP (Level 1 and Level 2) are observed in focal/segmental form.
Measured: 2 years
Diagnostic yield of EUS-FNB in this patient population.
The sensitivity, specificity, PPV, NPV, and accuracy calculated in comparison with the final diagnosis
Measured: 2 years
The rate of pancreatic neoplasms mimicking AIP
The percentage of pancreatic neoplasm in the study population
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 May 2020
- Primary completion1 Jun 2022
- Study completion1 Jun 2023
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Francesco Crinò, MD, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Stefano Francesco Crinò, Principal investigator, Azienda Ospedaliera Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397731
- Sponsor's protocol ID
- 2482CESC
- Acronym
- BIO_AIP
- Status last verified
- Mar 2021
- First submitted
- 18 May 2020
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Conti Bellocchi MC, Crino SF, Ikeura T, Carrara S, Oh D, Nakamaru K, Terrin M, Song TJ, Caldart F, Sina S, De Pretis N, Manfrin E, Frulloni L. Impact of EUS-guided fine-needle biopsy sampling on International Consensus Diagnostic Criteria for diagnosing autoimmune pancreatitis: a prospective multicenter study. Gastrointest Endosc. 2025 Oct;102(4):559-568.e1. doi: 10.1016/j.gie.2025.02.038. Epub 2025 Feb 28.
PubMed 40024297
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endoscopic Ultrasound-guided Fine-needle Biopsy in the Diagnosis of Autoimmune Pancreatitis
- ClinicalTrials.gov ID
- NCT04397731
- Acronym / sponsor ID
- BIO_AIP / 2482CESC
- Conditions
- Autoimmune Pancreatitis
- Keywords
- ICDC criteria, AIP, HISTOLOGY IN AIP, EUS-FNB, Endoscopic fine needle biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 21 May 2020 (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.
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 malignancy, could provide histological tissue samples useful in enhancing the diagnostic level reached without histology, or defining the type of AIP.
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 of EUS-FNB in this setting of patients; the possibility to obtain a definitive diagnosis in focal/segmental form of AIP (that are the most clinically relevant because of the mimicking of cancer); diagnostic yield of EUS-FNB in this patient population; the rate of pancreatic neoplasms mimicking AIP.
Consecutive patients ≥ 18 years old, with suspected focal or diffuse AIP, according to ICDC (probable type 1 AIP; probable type 2 AIP; NOS-AIP) with written consent to participate in the study will be enrolled.
Exclusion criteria include: previous diagnosis of AIP; definitive type 1 AIP; steroid administration within 3 months before the EUS-FNB; coagulation disorders; pregnancy and lactation; unability to give informed consent .
The histopathology of the preparations will be evaluated, according to the ICDC, including the LPSP findings and the IDCP findings and recording the absence or presence of specific criteria: Periductal lymphoplasmacytic infiltrate without GELs, Storiform fibrosis, Obliterative phlebitis >10 IgG4-positive cells per HPF; GEL of duct wall; Granulocytic and lympho- plasmacytic acinar infiltrate.
According to the current clinical practice, when the diagnosis of AIP is confirmed (and malignancy is ruled-out) patient will be treated with the standard therapy for AIP. Patients will be followed for 12 months, in order to exclude misdiagnosed malignancy, and to evaluate the clinical course of the disease (response to steroid therapy, relapses, changes in imaging findings or surgical pathology in resected patients).
The final diagnosis of AIP will be confirmed on surgical pathology (in resected patients) or when a compatible clinical course is observed during a follow-up of at least 1 year (significant improvement on imaging after steroid therapy, no appearance of metastasis or sign of infiltration).
The number of cases where EUS-FNB histology improves the diagnostic level will be summarized using absolute and relative frequencies. The 95% confidence interval of this proportion will also be computed. The number of adverse events, the number of cases where histological finding diagnostic of AIP are observed in focal/segmental form and the number of pancreatic neoplasm will be summarized using absolute and relative frequencies. Sensitivity, specificity, positive likelihood ratio (LR+), negative likelihood Ratio (LR-) and the ROC curve will be used to analyze the capability of EUS-FNB to obtain a definitive diagnosis of type 1 and 2 AIP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected AIP who need histological sampling for diagnosis.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Previous diagnosis of AIP
- Definitive type 1 AIP
- Steroid administration within 3 months before the EUS-FNB
- Coagulation disorders
- Pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 2 years
For the primary aim, the endpoint is the percentage of cases where EUS-FNB histology improve the diagnostic level: * from a probable AIP 1 to definitive AIP 1 (i.e., percentage of type 1 Level 1 H); * from a probable AIP 2 to definitive AIP 2 (i.e., percentage of type 2 Level 1 H); * from an AIP-NOS to AIP 1 or 2 (i.e., percentage of type 1 and 2, Level 1 H or Level 2 H).
4 secondary outcomes
Safety of EUS-FNB in AIP patients: percentage of adverse events observed
Time frame: 2 years
The possibility to obtain a definitive diagnosis in focal/segmental form of AIP (that are the most clinically relevant because of the mimicking of cancer).
Time frame: 2 years
Diagnostic yield of EUS-FNB in this patient population.
Time frame: 2 years
The rate of pancreatic neoplasms mimicking AIP
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 40024297Conti Bellocchi MC, Crino SF, Ikeura T, Carrara S, Oh D, Nakamaru K, Terrin M, Song TJ, Caldart F, Sina S, De Pretis N, Manfrin E, Frulloni L. Impact of EUS-guided fine-needle biopsy sampling on International Consensus Diagnostic Criteria for diagnosing autoimmune pancreatitis: a prospective multicenter study. Gastrointest Endosc. 2025 Oct;102(4):559-568.e1. doi: 10.1016/j.gie.2025.02.038. Epub 2025 Feb 28.
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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.
Stefano Francesco Crinò principal investigator
Azienda Ospedaliera Integrata Verona
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Pancreatitis, run by Azienda Ospedaliera Universitaria Integrata Verona at 2 sites in 2 countries.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 years). 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 NCT04397731, 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 7 Feb 2025.