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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | autoimmune pancreatitis | |
Classification by specialty |
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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 | |
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Purpose of intervention | |
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Eligibility | ||||
Age-lower limit |
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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. |
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Key exclusion criteria | Patients for whom consent could not be obtained | |||
Target sample size | 46 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Department of Internal Medicine,
Kobe University Graduate School of Medicine |
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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 |
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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 | |
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 |
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 |
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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 | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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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 |
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Last modified on |
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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 |