Clinical trial NCT04397731: Prospective Study on the Role of Eus-fnb in the Diagnosis of Autoimmune Pancreatitis
Official title: Role of Endoscopic Ultrasound-guided Fine-needle Biopsy in the Diagnosis of Autoimmune Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Pancreatitis
Keywords: ICDC criteria
AIP
HISTOLOGY IN AIP
EUS-FNB
Endoscopic fine needle biopsy
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected AIP who need histological sampling for diagnosis.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: 2 years
Secondary outcomes:
measure: Safety of EUS-FNB in AIP patients: percentage of adverse events observed
timeFrame: 2 years
measure: 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).
timeFrame: 2 years
measure: Diagnostic yield of EUS-FNB in this patient population.
timeFrame: 2 years
measure: The rate of pancreatic neoplasms mimicking AIP
timeFrame: 2 years
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Integrata Verona
city: Osaka
country: Japan
facility: Tsukasa Ikeura
Study officials:
affiliation: Azienda Ospedaliera Integrata Verona
name: Stefano Francesco Crinò
role: PRINCIPAL_INVESTIGATOR
References: