UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019500 |
|---|---|
| Receipt number | R000022541 |
| Scientific Title | Multicenter prospective observational study for usefulness of perfusion CT in early diagnosis of pancreatic ischemia in acute pancreatitis |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2015/11/16 13:27:32 |
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Basic information
Public title
Multicenter prospective observational study for usefulness of perfusion CT in early diagnosis of pancreatic ischemia in acute pancreatitis
Acronym
perfusion CT study(acute pancreatitis)
Scientific Title
Multicenter prospective observational study for usefulness of perfusion CT in early diagnosis of pancreatic ischemia in acute pancreatitis
Scientific Title:Acronym
perfusion CT study(acute pancreatitis)
Region
| Japan |
Condition
Condition
acute pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By comparing with contrast enhanced computed tomography(CE-CT),we investigate the usefulness of perfusion CT to diagnose pancreatic ischemia developing to pancreatic necrosis in the early stage of acute pancreatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
presence or absence of pancreatic necrosis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with acute pancreatitis admitted within 72hr after the symptom onset.
written informed consent
Key exclusion criteria
the case with contrast medium allergy
the case with renal insufficiency
the case with severe disease,which had better not to use contrast medium
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Takeda |
Organization
National Hospital Organization, Sendai Medical Center
Division name
Department of Surgery
Zip code
Address
2-8-8Miyagino,Miyagino-ku,Sendai,Miyagi
TEL
022-293-1111
kktakeda@snh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satomi Kida |
Organization
National Hospital Organization, Sendai Medical Center
Division name
Department of management
Zip code
Address
2-8-8Miyagino,Miyagino-ku,Sendai,Miyagi
TEL
022-293-1111
Homepage URL
syokuin2132@snh.go.jp
Sponsor or person
Institute
Japan Pancreas Society
Institute
Department
Personal name
Funding Source
Organization
Japan Pancreas Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japan Pancreas Society
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 11 | 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
| 2015 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | 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
By comparing with contrast enhanced computed tomography(CE-CT),we investigate the usefulness of perfusion CT to diagnose pancreatic ischemia developing to pancreatic necrosis in the early stage of acute pancreatitis.
[Study design]A case control study.
[Recruitment information]Patients with acute pancreatitis admitted in hospitals of our study group between January 2016 and December 2019 who correspond to inclusion criteria.Patients in whom written informed consent was obtained.
Management information
Registered date
| 2015 | Year | 10 | Month | 26 | Day |
Last modified on
| 2015 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022541
