UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020142 |
|---|---|
| Receipt number | 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 | 2024/12/16 09:12:34 |
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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 | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido Univesity Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
0608648
Address
W-5, N-14, KIta-ku, Sapporo
TEL
0117161161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kuwatani |
| Middle name | |
| Last name | Masaki |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
0608648
Address
W-5, N-14, KIta-ku, Sapporo
TEL
0117161161
Homepage URL
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Address
W-5, N-14, KIta-ku, Sapporo
Tel
0117067636
crjimu@huhp.hokudai.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
| 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
50
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective observational study
Patients who visit our hospital from October 2015 to December 2022 and meet the inclusion criteria
Management information
Registered date
| 2015 | Year | 12 | Month | 10 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023261
