UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043860 |
|---|---|
| Receipt number | R000050058 |
| Scientific Title | Post ERCP pancreatitis Prediction System using a "Big 5" simple score for clinical decision-making in immediately after ERCP: a multicenter, prospective validation study |
| Date of disclosure of the study information | 2021/04/08 |
| Last modified on | 2023/01/18 14:21:21 |
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Basic information
Public title
Post ERCP pancreatitis Prediction System using a "Big 5" simple score for clinical decision-making in immediately after ERCP: a multicenter, prospective validation study
Acronym
PEP Prediction System using a "Big 5" simple score for clinical decision-making in immediately after ERCP
Scientific Title
Post ERCP pancreatitis Prediction System using a "Big 5" simple score for clinical decision-making in immediately after ERCP: a multicenter, prospective validation study
Scientific Title:Acronym
PEP Prediction System using a "Big 5" simple score for clinical decision-making in immediately after ERCP
Region
| Japan |
Condition
Condition
Patients who undergo ERCP with trans-papilla.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the external validity of predictive scoring system for post ERCP pancreatitis immediately after ERCP, which was developed previously.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To verify the usefulness and external validity of this scoring system, we evaluate predictive diagnostic ability using Receiver Operating Characteristic analysis and the area under the curve.
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Consecutive patients with suspected hepatobiliary-pancreatic disorders who undergo trans-papillary ERCP attempts.
2. Patients who are obtained written informed consent to undergo ERCP.
Key exclusion criteria
Patients or patients' family who reject the participation in this study, when the opportunity to opt out of this study participation was also provided.
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Chiba |
Organization
The Jikei University School of Medicine, Tokyo, Japan
Division name
Department of Endoscopy
Zip code
1058461
Address
3-25-8 Nishi-Shimbashi Minato-ku Tokyo Japan
TEL
334331113181
ccl09720@gmail.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Chiba |
Organization
The Jikei University School of Medicine, Tokyo, Japan
Division name
Department of Endoscopy
Zip code
1058461
Address
3-25-8 Nishi-Shimbashi Minato-ku Tokyo Japan
TEL
334331113181
Homepage URL
ccl09720@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine affiliated hospital.
The Jikei University Katsushika Medical Center.
The Jikei University Kashiwa Hospital.
Atsugi city hospital
Fuji city general hospital.
Institute
Department
Personal name
Funding Source
Organization
self-funding (The Jikei University School of Medicine)
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
Human Subjects Committee of Jikei University School of Medicine
Address
3-25-8 Nishi-Shimbashi Minato-ku Tokyo Japan
Tel
+81 3 34331111, ext. 2134
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
32-456 (10548)
Org. issuing International ID_1
Human Subjects Committee of Jikei University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京慈恵会医科大学附属病院 東京慈恵会医科大学葛飾医療センター 東京慈恵会医科大学柏病院 厚木市立病院 富士市立中央病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | 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
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter prospective cohort study including consecutive patients with suspected hepatobiliary-pancreatic disorders who undergo trans-papillary ERCP attempts between April 1, 2021 and September 30, 2023.
Management information
Registered date
| 2021 | Year | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050058
