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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034194
Receipt No. R000038636
Scientific Title Evaluation of the corticosteroids therapy without biliary stenting in patients with obstructive jaundice due to autoimmune pancreatitis
Date of disclosure of the study information 2018/12/01
Last modified on 2019/03/21

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Basic information
Public title Evaluation of the corticosteroids therapy without biliary stenting in patients with obstructive jaundice due to autoimmune pancreatitis
Acronym ECO-JAPAN study
Scientific Title Evaluation of the corticosteroids therapy without biliary stenting in patients with obstructive jaundice due to autoimmune pancreatitis
Scientific Title:Acronym ECO-JAPAN study
Region
Japan

Condition
Condition Type 1 autoimmune pancreatitis (AIP)
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the safety and effectiveness of treatment of
obstructive jaundice with corticosteroids alone in definitive AIP without biliary stenting.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase II

Assessment
Primary outcomes The rate of improvement of liver tests after corticosteroid treatment in AIP patients.
Key secondary outcomes 1. Steroid-related adverse events (e.g. developed cholangitis or other infectious complications during steroid treatment)
2. Recurrent rate of obstructive jaundice during steroid treatment
3. Steroid-related complications
4. Comparing with control group about the above and medial expense

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 without biliary stenting
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with suspect of type 1 autoimmune pancreatitis
Agree to consent form
Patients with ECOG performance status 0 or 1
Key exclusion criteria 1) Liver dysfunction with viral hepatitis
2) Patients with acute cholangitis
3) Patients with ASA criteria 3, 4, or 5
4) Uncooperative patients
5) Refusal to consent form
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Kurita
Organization Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name Division of Gastroenterology and Hepatology, Digestive Disease Center
Zip code 530-8480
Address 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
TEL 06-6131-2662
Email kuritaaki1976@gmail.com

Public contact
Name of contact person
1st name Akira
Middle name
Last name Kurita
Organization Kitano Hospital, Tazuke Kofukai Medical Research Institute
Division name Division of Gastroenterology and Hepatology, Digestive Disease Center
Zip code 530-8480
Address 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
TEL 06-6131-2662
Homepage URL
Email kuritaaki1976@gmail.com

Sponsor
Institute Bilio-Pancreatic Stenting study group
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 Kitano Hospital, Ethics Committe
Address 2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.
Tel 06-6131-2662
Email rinshou@kitano-hp.or.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 大阪医科大学附属病院(大阪府)、関西医科大学附属病院(大阪府)、大阪市立大学医学部附属病院(大阪府)、近畿大学医学部附属病院(大阪府)、北野病院(大阪府)、大阪赤十字病院(大阪府)、天理よろづ相談所病院(奈良県)、神戸大学医学部附属病院(兵庫県)、川崎医科大学附属総合医療センター(岡山県)、福岡大学筑紫病院(福岡県)、宮崎大学医学部附属病院(宮崎県)、熊本大学医学部附属病院(熊本県)、和歌山県立医科大学附属病院(和歌山県)、鹿児島大学医学部附属病院(鹿児島県)、大阪国際がんセンター(大阪府)、鳥取赤十字病院(鳥取県)、北播磨総合医療センター(兵庫県)、島根大学医学部附属病院(島根県)、京都桂病院(京都ふ)、京都府立医科大学附属病院(京都府)、広島赤十字・原爆病院(広島県)、久留米大学医学部附属病院(福岡県)、淀川キリスト教病院(大阪府)、済生会中津病院(大阪府)、香川大学医学部附属病院(香川県)、鳥取大学医学部附属病院(鳥取県)、ベルランド総合病院(大阪府)、大阪大学医学部附属病院(大阪府)、大阪市立総合医療センター(大阪府)、JA尾道総合病院(広島県)、日赤和歌山医療センター(和歌山県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 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
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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 09 Month 18 Day
Last modified on
2019 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038636

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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