UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039419
Receipt number R000044940
Scientific Title Prediction of the Progression of Walled-off Necrosis in Patients with Acute Pancreatitis on Whole Pancreatic Perfusion CT
Date of disclosure of the study information 2020/02/10
Last modified on 2020/02/06 21:13:08

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Basic information

Public title

Prediction of the Progression of Walled-off Necrosis in Patients with Acute Pancreatitis on Whole Pancreatic Perfusion CT

Acronym

Prediction of the Progression of Walled-off Necrosis in Patients with Acute Pancreatitis on Whole Pancreatic Perfusion CT

Scientific Title

Prediction of the Progression of Walled-off Necrosis in Patients with Acute Pancreatitis on Whole Pancreatic Perfusion CT

Scientific Title:Acronym

Prediction of the Progression of Walled-off Necrosis in Patients with Acute Pancreatitis on Whole Pancreatic Perfusion CT

Region

Japan


Condition

Condition

Acute pancreatitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether measuring pancreatic blood volume (PBV) on whole pancreatic P-CT can detect pancreatic ischemic changes and predict of the progression of walled-off necrosis (WON) in patients with AP.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To determine the usefulness for the prediction of WON of the minimum PBV measurement on whole pancreatic P-CT.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients with acute pancreatitis

Key exclusion criteria

The patients who cannot undergo whole pancreatic P-CT

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Yamamiya

Organization

Dokkyo Medical University

Division name

Department of Gastroenterology

Zip code

321-0293

Address

880 Kitakobayashi Mibu Tochigi, Japan.

TEL

0282872147

Email

akira-y@dokkyomed.ac.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Yamamiya

Organization

Dokkyo Medical University

Division name

Department of Gastroenterology

Zip code

321-0293

Address

880 Kitakobayashi Mibu Tochigi, Japan.

TEL

0282872147

Homepage URL


Email

akira-y@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Dokkyo Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Dokkyo Medical University

Address

880 Kitakobayashi Mibu Tochigi, Japan.

Tel

0282872147

Email

akira-y@dokkyomed.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

昭和大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 10 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

2015 Year 04 Month 01 Day

Date of IRB

2017 Year 09 Month 13 Day

Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2020 Year 02 Month 06 Day

Last modified on

2020 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044940


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name