UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026692 |
|---|---|
| Receipt number | 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 18:42:07 |
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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
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
ishitaku@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030648
