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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019500
Receipt No. 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

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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
Email 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
Email syokuin2132@snh.go.jp

Sponsor
Institute Japan Pancreas Society
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022541

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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