UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037491 |
|---|---|
| Receipt number | 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 21:10:28 |
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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
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
kmuvfbi@yahoo.co.jp
Sponsor or person
Institute
Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042739
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