UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033041 |
|---|---|
| Receipt number | R000037674 |
| Scientific Title | Long-term Impact of Acute Pancreatitis on Patients' Quality of Life: A Multi-center Prospective Study |
| Date of disclosure of the study information | 2018/06/18 |
| Last modified on | 2024/12/21 01:06:22 |
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Basic information
Public title
Long-term Impact of Acute Pancreatitis on Patients' Quality of Life: A Multi-center Prospective Study
Acronym
LONG-TONE study
Scientific Title
Long-term Impact of Acute Pancreatitis on Patients' Quality of Life: A Multi-center Prospective Study
Scientific Title:Acronym
LONG-TONE study
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
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
mu13951@kchnet.or.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology,
Kurashiki Central Hospital
Institute
Department
Personal name
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
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
（2021年6月13日時点、順不同）
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）
大阪赤十字病院（大阪府）
横浜市立大学附属病院（神奈川県）
札幌医科大学附属病院（北海道）
京都大学医学部附属病院（京都府）
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
284
Results
At 3 months (N=234), 50 patients (21.4%) reported a decline in overall QOL. Although no significant difference in physical QOL was observed between the baseline and 3 months, a significant decline in physical component scores was noted in patients with deteriorated overall QOL. The severity of acute pancreatitis, length of hospital stay, and ICU admission were siginificantly associated with the deterioration of overall QOL. At 12 months (N=214), 43 patients (20.1%) reported a deterioration in overall QOL.
Results date posted
| 2024 | Year | 12 | Month | 21 | Day |
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
Completed
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
| 2023 | 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
| 2024 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037674
