UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056656 |
|---|---|
| Receipt number | R000064734 |
| Scientific Title | Development of a dedicated test kit for early prediction of post-endoscopic retrograde cholangiopancreatography pancreatitis |
| Date of disclosure of the study information | 2025/01/08 |
| Last modified on | 2025/01/07 22:03:28 |
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Basic information
Public title
Development of a dedicated test kit for early prediction of post-endoscopic retrograde cholangiopancreatography pancreatitis
Acronym
Development of a dedicated test kit for post-ERCP pancreatitis
Scientific Title
Development of a dedicated test kit for early prediction of post-endoscopic retrograde cholangiopancreatography pancreatitis
Scientific Title:Acronym
Development of a dedicated test kit for post-ERCP pancreatitis
Region
| Japan |
Condition
Condition
Post-endoscopic retrograde cholangiopancreatography pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the predictive ability of blood trypsinogen-2 for post-ERCP pancreatitis and explore the potential for developing a dedicated test kit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Predictive ability of blood trypsinogen-2 for PEP at 1 hour post-ERCP: Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value
Key secondary outcomes
Predictive ability of serum amylase for PEP at 1 hour post-ERCP
Incidence rate and severity of PEP
Incidence rate and severity of ERCP-related and fluid-related complications other than PEP.
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 who are scheduled to undergo initial ERCP for diagnosis or treatment of biliopancreatic diseases.
Cases in which the patient is 20 years of age or older and able to obtain written consent (written consent from a surrogate is also acceptable)
Key exclusion criteria
Cases of acute pancreatitis
Cases of bile duct jejunal anastomosis
Other cases judged to be inappropriate for participation in this study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Naminatsu |
| Middle name | |
| Last name | Takahara |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-3815-5411
naminatsu-takahara@umin.ac.jp
Public contact
Name of contact person
| 1st name | Rintaro |
| Middle name | |
| Last name | Fukuda |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-3815-5411
Homepage URL
https://todai-tansui.com/research/
rfukuda-jun@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Operational Grant
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
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
+81-3-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024429NI
Org. issuing International ID_1
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学医学部附属病院(東京都)、ニプロ株式会社(大阪府)、日本赤十字社医療センター(東京都)、関東中央病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 08 | 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
| 2024 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
A multicenter prospective cohort study
Management information
Registered date
| 2025 | Year | 01 | Month | 07 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064734
