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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037491
Receipt No. R000042739
Scientific Title Prediction of pancreatic atrophy after steroid therapy using equilibrium phase contrast CT imaging in autoimmune pancreatitis
Date of disclosure of the study information 2019/07/25
Last modified on 2019/07/25

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Basic information
Public title Prediction of pancreatic atrophy after steroid therapy using equilibrium phase contrast CT imaging in autoimmune pancreatitis
Acronym Equilibrium CT and pancreatic atrophy in AIP
Scientific Title Prediction of pancreatic atrophy after steroid therapy using equilibrium phase contrast CT imaging in autoimmune pancreatitis
Scientific Title:Acronym Equilibrium CT and pancreatic atrophy in AIP
Region
Japan

Condition
Condition autoimmune pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In autoimmune pancreatitis (AIP), imaging tools for predicting pancreatic atrophy after steroid therapy have not been established. Delayed contrast enhancement in the equilibrium phase of contrast-enhanced computed tomography (CE-CT) has been reported to reflect interstitial fibrosis. We thus aimed to evaluate the predictive ability of equilibrium phase CT imaging for pancreatic atrophy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to evaluate the predictive ability of equilibrium phase CT imaging for pancreatic atrophy after steroid therapy in autoimmune pancreatitis
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. AIP patients who could be obtained clinical information and prognosis
2. From December 2005 to December 2017, AIP patients treated with steroid therapy, who underwent CE-CT in Kobe university hospital, were enrolled in this study.
Key exclusion criteria Patients for whom consent could not be obtained
Target sample size 46

Research contact person
Name of lead principal investigator
1st name Atsuhiro
Middle name
Last name Masuda
Organization Department of Internal Medicine,
Kobe University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code 650-0017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL 078-382-6305
Email atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Yasutaka
Middle name
Last name Yamada
Organization Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code 650-0017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL 078-382-6305
Homepage URL
Email kmuvfbi@yahoo.co.jp

Sponsor
Institute Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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 the ethical committee at the Kobe University School of Medicine Ethics Committee
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel 078-382-6669
Email rinri@med.kobe-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 No. 180229
Org. issuing International ID_1 the ethical committee at the Kobe University School of Medicine Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 46
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
2018 Year 10 Month 15 Day
Anticipated trial start date
2018 Year 10 Month 16 Day
Last follow-up date
2019 Year 05 Month 30 Day
Date of closure to data entry
2019 Year 06 Month 30 Day
Date trial data considered complete
2019 Year 07 Month 01 Day
Date analysis concluded
2019 Year 07 Month 01 Day

Other
Other related information Medical records were examined, and information on demographics (age and gender), alcohol intake (>50 g/day), serum IgG4, current smoking, and diabetes was collected. The pattern of pancreas swelling (diffuse or focal/segmental) and other organ involvement were also examined by imaging studies, including CT scans.

Management information
Registered date
2019 Year 07 Month 25 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042739

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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