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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020142
Receipt No. R000023261
Scientific Title CT perfusion of the pancreas: Evaluation of predictive factors in acute pancreatitis related to endoscopic retrograde cholangiopancreatography (post-ERCP pancreatitis)
Date of disclosure of the study information 2015/12/14
Last modified on 2017/06/11

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Basic information
Public title CT perfusion of the pancreas: Evaluation of predictive factors in acute pancreatitis related to endoscopic retrograde cholangiopancreatography (post-ERCP pancreatitis)
Acronym CT perfusion of the pancreas: Evaluation of predictive factors in acute pancreatitis related to post-ERCP pancreatitis
Scientific Title CT perfusion of the pancreas: Evaluation of predictive factors in acute pancreatitis related to endoscopic retrograde cholangiopancreatography (post-ERCP pancreatitis)
Scientific Title:Acronym CT perfusion of the pancreas: Evaluation of predictive factors in acute pancreatitis related to post-ERCP pancreatitis
Region
Japan

Condition
Condition Bile duct of pancreatic disease
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To detect the predictive factors of post-ERCP pancreatitis in CT perfusion findings after ERCP
Basic objectives2 Others
Basic objectives -Others Image data analysis
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Blood volume of the pancreas after ERCP
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 1) Scheduled ERCP for bile duct or pancreatic disease exam.
2) 20 years old of more.
3) Included in high risk group of post-ERCP pancreatitis (PEP) (meeting the following A or B)
(A) Meeting one or more of the following factors
i) Sphincter of Oddi dysfunction
ii) History of PEP
iii) Pancreatic sphincterotomy
iv) Pancreatic sphincter precutting (upward incision precut)
v) Difficult catheter insertion (10 min or more for cannulation, of 10 times or more of bile duct approach)
vi) Vater sphincterotomy
(B) Meeting two or more of the following factors.
i) 50 years old or less
ii) Womem
iii) History of pancreatitis
iv) Pancreatography or insertion of guide wire into the pancreatic duct
v) Papillary balloon dilatation
4) Written informed consent is obtained.
Key exclusion criteria 1) Absolute contraindication to iodinated contrast material
2) eGFR < 30mL/min/1.73m2
3) New York heart association classification: class III or IV.
4) Severe lung disfunction
5) Impossible to perform ERCP because of digestive tract stenosis or trismus
6) Eastern Cooperative Oncology Group performance status 4
7) Pregnant or lactating women
8) Excluded by study directors because of other considerable factor(s)
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Sakuhara
Organization Hokkaido Univesity Hospital
Division name Department of Diagnostic and Interventional Radiology
Zip code
Address W-5, N-14, KIta-ku, Sapporo
TEL 0117161161
Email yusaku@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Kuwatani
Organization Hokkaido University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address W-5, N-14, KIta-ku, Sapporo
TEL 0117161161
Homepage URL
Email mkuwatan@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Not applicable
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
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 12 Month 14 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 Enrolling by invitation
Date of protocol fixation
2015 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study
Patients who visit our hospital from October 2015 to December 2018 and meet the inclusion criteria

Management information
Registered date
2015 Year 12 Month 10 Day
Last modified on
2017 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023261

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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