Prospective Study on the Role of Eus-fnb in the Diagnosis of Autoimmune Pancreatitis

NCT04397731 | Completed

• 1 other identifier: 2482CESC
• Study Type: observational
• Target: 52
• Locations: 2 countries
• Sites: 2

Brief 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 defining the type of AIP.

Conditions

Autoimmune Pancreatitis

Keywords

ICDC criteria; AIP; HISTOLOGY IN AIP; EUS-FNB; Endoscopic fine needle biopsy

Outcome Measures

Primary Outcomes (1)

• 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).

  2 years

Secondary Outcomes (4)

• Safety of EUS-FNB in AIP patients: percentage of adverse events observed

  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).

  2 years

• Diagnostic yield of EUS-FNB in this patient population.

  2 years

• The rate of pancreatic neoplasms mimicking AIP

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected AIP who need histological sampling for diagnosis.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (2)

Azienda Ospedaliera Integrata Verona

Verona, 37134, Italy

Location

Tsukasa Ikeura

Osaka, Japan

Location

Related Publications (1)

• 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.

  PMID: 40024297 DERIVED

MeSH Terms

Conditions

Autoimmune Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatitis, Chronic; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Francesco Crinò

  Azienda Ospedaliera Integrata Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: May 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: February 7, 2025

Record last verified: 2021-03

Locations

IT (1); JP (1)