UMIN-CTR Clinical Trial

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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