UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000026692
Receipt No. R000030648
Scientific Title Multicenter study on the usefulness of EUS-FNB in the diagnosis of autoimmune pancreatitis
Date of disclosure of the study information 2017/05/01
Last modified on 2020/09/25 (Ver. 9)

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Basic information
Public title Multicenter study on the usefulness of EUS-FNB in the diagnosis of autoimmune pancreatitis
Acronym Usefulness of EUS-FNB tiral in AIP diagnosis
Scientific Title Multicenter study on the usefulness of EUS-FNB in the diagnosis of autoimmune pancreatitis
Scientific Title:Acronym Usefulness of EUS-FNB tiral in AIP diagnosis
Region
Japan

Condition
Condition Autoimmune pancreaitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Exploring the usefulness of EUS-guided fine needle biopsy (FNB) using a new needle (AcquireTM) for the diagnosis of autoimmune pancreatitis (AIP).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate of pathological findings which meet level 1 of international consensus diagnostic criteria for AIP (ICDC) by EUS-FNB
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 A specific needle (AcquireTM) is used for EUS-guided tissue sampling. Once only.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients who meet image criteria of AIP on ICDC and have not treated before.
(2) Patients between 20 and 80 years old at the time of enrollment.
(3) Performance status of 0 to 1.
(4) Preservation of main organ functions at the time of diagnosis.
(5) Provision of written consent to participate in the study.
Key exclusion criteria (1) Steroid administration within 3 months before the initiation of treatment.
(2) Poorly controlled infection (including active tuberculosis).
(3) Serious drug allergy.
(4) Difficult in observation of the course of endoscopy.
(5) Malignant tumor.
(6) Serious adverse events.
(7) Pregnant and lactating women, women who are possibly pregnant, and women who might want to become pregnant.
(8) Severe mental disorder
(9) Judgement as being ineligible by the principal or subinvestigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoshiki
Middle name
Last name Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550
TEL 052-744-2602
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Ishikawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550
TEL 052-744-2602
Homepage URL
Email ishitaku@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Nagoya University Hospital
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel 0527441958
Email center@med.nagoya-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://pubmed.ncbi.nlm.nih.gov/32583394/
Number of participants that the trial has enrolled 56
Results 
EUS-FNB with a 22-gauge Franseen needle demonstrated favorable detection rates which would be clinically beneficial for the histological diagnosis of autoimmune pancreatitis.
Results date posted
2020 Year 09 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 06 Month 24 Day
Baseline Characteristics 
Forty-one of 56 patients were male, and the mean age was 66.7 years old. Fifty-five patients were clinically suspected to have type 1 AIP and only one patient was suspected to have type 2 AIP without histologic analysis.
Participant flow 
Assessed for eligibility (Suspected AIP by imaging) (n=62)

Excluded
Not met the imaging criteria (n=3)
Diagnosed with pancreatic cancer by EUS-FNB (n=1)
Treated with steroid within 3 months before enrollment (n=1)
Tissue sample not sent to Nagoya University (n=1)

Enrolled for the study (n=56)
Adverse events 
Two patients (4%) developed mild post-procedural abdominal pain immediately after the procedure, but they recovered within 24 hours without medication, and no patients required prolongation of admission due to adverse events. No other adverse events related to the EUS-FNB procedure were reported
Outcome measures 
Lymphoplasmacytic infiltration, obliterative phlebitis, storiform fibrosis, and >10 IgG4-positive cells per high-power field were detected in 55 (100%), 24 (43.6%), 40 (72.7%), and 36 (65.4%) of 55 patients, respectively. The detection rates of level 1 and level 1 or 2 histology for AIP were 58.2% (95% confidence interval (CI) [44.1-71.3]) and 92.7% (95% CI [82.4-98]), respectively, which were apparently higher than our historical results (7.9%, 95% CI [1.7-21.4] and 62.2%, 95% CI [46.5-76.2]) using a conventional needle.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 03 Month 24 Day
Date of IRB
2017 Year 05 Month 23 Day
Anticipated trial start date
2017 Year 05 Month 23 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 24 Day
Last modified on
2020 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030648