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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033041
Receipt No. R000037674
Scientific Title A multi-center prospective cohort study of quality of life after acute pancreatitis
Date of disclosure of the study information 2018/06/18
Last modified on 2019/12/27

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Basic information
Public title A multi-center prospective cohort study of quality of life after acute pancreatitis
Acronym A multi-center prospective cohort study of quality of life after acute pancreatitis
Scientific Title A multi-center prospective cohort study of quality of life after acute pancreatitis
Scientific Title:Acronym A multi-center prospective cohort study of quality of life after acute pancreatitis
Region
Japan

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

Objectives
Narrative objectives1 To elucidate how patients' quality of life changes after acute pancreatitis and identify the risk factors of decreased quality of life.
Basic objectives2 Others
Basic objectives -Others In treatment of acute pancreatitis, maintaining patients' quality of life is important, not only saving their lives. However, no large studies focusing on quality of life after acute pancreatitis have been conducted in Japan.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Quality of life (physical component) of patients three months after acute pancreatitis.
Key secondary outcomes 1) Quality of life of patients after acute pancreatitis (whole and each component, three months and one year after acute pancreatitis)
2) Changes of quality of life, stratified by the etiology and severity of acute pancreatitis
3) Total costs of in-hospital treatment
4) Number of outpatient visits and imaging examinations for follow-up or treatment related to pancreatitis within one year
5) Participation in their jobs and/or social activities at three months and one year after acute pancreatitis

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Diagnosed as acute pancreatitis according to revised Atlanta criteria and treated in hospital
2) Informed consent obtained
Key exclusion criteria 1) Diagnosed as chronic pancreatitis before inclusion
2) Treatment for 24 hours or more at other institutions before arrival
3) Pancreatitis which occurs during hospitalization
4) Impossible to answer correctly to the questions about quality of life
5) Alcohol abuse
6) Mental disorders requiring treatment by psychiatrist
7) Severe organ dysfunction or immunodeficiency (defined in APACHE2)
8) Considered as inappropriate by study investidators
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Ueno
Organization Kurashiki Central Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 710-8602
Address 1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL 086-422-0210
Email mu13951@kchnet.or.jp

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Ueno
Organization Kurashiki Central Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 710-8602
Address 1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL 086-422-0210
Homepage URL
Email mu13951@kchnet.or.jp

Sponsor
Institute Department of Gastroenterology and Hepatology,
Kurashiki Central Hospital
Institute
Department

Funding Source
Organization Japan Pancreas Society
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kurashiki Central Hospital Ethics Committee
Address 1-1-1 Miwa, Kurashiki, Okayama, Japan
Tel 086-422-0210
Email kurari-net@kchnet.or.jp

Secondary IDs
Secondary IDs YES
Study ID_1 2018-01
Org. issuing International ID_1 Japan Pancreas Society
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions (2019年12月20日時点、順不同)
千葉大学医学部附属病院(千葉県)
京都府立医科大学(京都府)
名古屋大学(愛知県)
和歌山県立医科大学(和歌山県)
藤田医科大学ばんたね病院(愛知県)
富山大学附属病院(富山県)
東北大学(宮城県)
東京医科大学茨城医療センター(茨城県)
福岡大学筑紫病院(福岡県)
東京女子医科大学(東京都)
関西医科大学附属病院(大阪府)
滋賀医科大学(滋賀県)
近畿大学(大阪府)
京都桂病院(京都府)
三田市民病院(兵庫県)
大阪府済生会中津病院(大阪府)
倉敷中央病院(岡山県)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 18 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 Open public recruiting
Date of protocol fixation
2018 Year 06 Month 18 Day
Date of IRB
2018 Year 04 Month 18 Day
Anticipated trial start date
2018 Year 06 Month 18 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information As soon as informed consent is obtained, assess patient's quality of life before and just after developing acute pancreatitis, according to SF-12. For those who cannot answer the question appropriately at admission, the assessment can be delayed until the patients get able to answer.
At three months and twelve months after developing acute pancreatitis, patient's quality of life is assessed in the same way.

Management information
Registered date
2018 Year 06 Month 18 Day
Last modified on
2019 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037674

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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