UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040471 |
|---|---|
| Receipt number | R000046196 |
| Scientific Title | The milestone for preventing post-ERCP pancreatitis using novel simplified predictive scoring system: A Propensity Score Analysis |
| Date of disclosure of the study information | 2020/05/22 |
| Last modified on | 2020/12/01 19:58:38 |
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Basic information
Public title
The milestone for preventing post-ERCP pancreatitis using novel simplified predictive scoring system: A Propensity Score Analysis
Acronym
Prediction model for PEP
Scientific Title
The milestone for preventing post-ERCP pancreatitis using novel simplified predictive scoring system: A Propensity Score Analysis
Scientific Title:Acronym
Prediction model for PEP
Region
| Japan |
Condition
Condition
Consecutive trans-papillary ERCP procedures were retrospectively analyzed.
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to establish a simplified predictive scoring system for PEP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After a predictive scoring system for PEP was established, the usability of the present model was evaluated. The results were also internally validated using bootstrapping resampling.
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
The present study was a retrospective single-center cohort study including consecutive patients with suspected hepatobiliary-pancreatic disorders who underwent trans-papillary ERCP attempts between January 1, 2012 and December 31, 2019.
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
3362
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
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
ccl09720@gmail.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Chiba |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Homepage URL
ccl09720@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
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
32-027 (10102)
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病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00464-020-08173-4
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00464-020-08173-4
Number of participants that the trial has enrolled
3362
Results
Chiba, M., Kato, M., Kinoshita, Y. et al. The milestone for preventing post-ERCP pancreatitis using novel simplified predictive scoring system: a propensity score analysis. Surg Endosc (2020). https://doi.org/10.1007/s00464-020-08173-4
Results date posted
| 2020 | Year | 12 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The present study was a retrospective single-center cohort study including consecutive patients with suspected hepatobiliary-pancreatic disorders who underwent trans-papillary ERCP attempts between January 1, 2012 and December 31, 2019.
Management information
Registered date
| 2020 | Year | 05 | Month | 21 | Day |
Last modified on
| 2020 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046196
