UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046931 |
|---|---|
| Receipt number | R000053440 |
| Scientific Title | Early prediction of post-endoscopic retrograde cholangiopancreatography pancreatitis |
| Date of disclosure of the study information | 2022/02/18 |
| Last modified on | 2024/08/19 09:18:16 |
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Basic information
Public title
Early prediction of post-endoscopic retrograde cholangiopancreatography pancreatitis
Acronym
Early prediction of post-endoscopic retrograde cholangiopancreatography pancreatitis
Scientific Title
Early prediction of post-endoscopic retrograde cholangiopancreatography pancreatitis
Scientific Title:Acronym
Early prediction of post-endoscopic retrograde cholangiopancreatography pancreatitis
Region
| Japan |
Condition
Condition
Patients scheduled to undergo ERCP
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an effectiveness of blood test, urinalysis and a predictive model for an early diagnosis of post-ERCP pancreatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of urine trypsinogen-2 immediately after and 1 hour after ERCP.
Comparison of an effectiveness of urine trypsinogen-2 and blood test 3 hours after ERCP.
Effectiveness of a predictive model of post-ERCP pancreatitis.
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 who are scheduled to undergo ERCP and with their age at least 20 years old.
Key exclusion criteria
Patients with acute pancreatitis at the time of ERCP and patients with severe renal impairment.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Nakai |
Organization
The University of Tokyo Hospital, Tokyo, Japan
Division name
Department of Endoscopy and Endoscopic Surgery
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3815-5411
nakaiy-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Rintaro |
| Middle name | |
| Last name | Fukuda |
Organization
The University of Tokyo Hospital, Tokyo, Japan
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3815-5411
Homepage URL
rintaro.fukuda@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, The University of Tokyo Hospital, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital, Tokyo, Japan
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 Japan
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021331NI
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 18 | 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
2578
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
| 2022 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Patients undergoing ERCP between 18 January 2022 and 30 June 2024
Management information
Registered date
| 2022 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053440
