UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035063 |
|---|---|
| Receipt number | R000039923 |
| Scientific Title | Risk factors associated walled-off necrosis with severe acute pancreatitis: a multicenter retrospective observational study |
| Date of disclosure of the study information | 2018/11/29 |
| Last modified on | 2021/05/31 09:13:43 |
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Basic information
Public title
Risk factors associated walled-off necrosis with severe acute pancreatitis: a multicenter retrospective observational study
Acronym
A observational study to evaluate risk factors for WON with severe acute pancreatitis (WON-SAP study)
Scientific Title
Risk factors associated walled-off necrosis with severe acute pancreatitis: a multicenter retrospective observational study
Scientific Title:Acronym
A observational study to evaluate risk factors for WON with severe acute pancreatitis (WON-SAP study)
Region
| Japan |
Condition
Condition
severe acute pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the risk factors for WON associated with severe acute pancreatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of WON at 28 days after acute pancreatitis onset and risk factors for WON.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with SAP within 48 h after admission according to the Japanese severity criteria for AP.
Key exclusion criteria
Patients who was not observed more than 28 days.
Patients who was not evaluated presence of WON.
Patients who had incomplete data at admission.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Terai |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Gastroenterology and Hepatology
Zip code
951-8510
Address
1-757, Asahimachidori, Chuo-ku, NIigata 951-8510, Japan
TEL
025-227-2207
terais@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Ikarashi |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Gastroenterology and Hepatology
Zip code
951-8510
Address
1-757, Asahimachidori, Chuo-ku, NIigata 951-8510, Japan
TEL
025-227-2207
Homepage URL
s-ikarashi@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
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
Niigata University
Address
1-754, Asahimachidori, Chuo-ku, NIigata 951-8520, Japan
Tel
025-227-2625
ethics@adm.niigata-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 29 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
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 | 11 | Month | 28 | Day |
Last modified on
| 2021 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039923
