UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037640 |
|---|---|
| Receipt number | R000042910 |
| Scientific Title | Best Period to Replace or Change Plastic Stents with Self-Expandable Metallic Stents Using Multivariate Competing Risk Regression Analysis: A Single-Center Retrospective Cohort Study |
| Date of disclosure of the study information | 2019/08/09 |
| Last modified on | 2020/08/05 12:02:22 |
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Basic information
Public title
Best Period to Replace or Change Plastic Stents with Self-Expandable Metallic Stents Using Multivariate Competing Risk Regression Analysis: A Single-Center Retrospective Cohort Study
Acronym
The best period to replace or change plastic stent to SEMS
Scientific Title
Best Period to Replace or Change Plastic Stents with Self-Expandable Metallic Stents Using Multivariate Competing Risk Regression Analysis: A Single-Center Retrospective Cohort Study
Scientific Title:Acronym
The best period to replace or change plastic stent to SEMS
Region
| Japan |
Condition
Condition
Consecutive patients with suspected hepatobiliary-pancreatic disorders who underwent EBD attempts between January 1, 2012, and December 31, 2018, were retrospectively included in this study. Data on ERCP procedures were retrieved from the Jikei University ERCP database, with more than 6 months of follow up.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study was to determine the best period to replace or change a Plastic stent (PS) with a Self-expandable metallic stent (SEMS) in each disease, after resolving the risk factors for recurrent biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint of the present study was the period to recurrent biliary obstruction(PRBO) in each disease.Consecutive patients with suspected hepatobiliary-pancreatic disorders who underwent EBD attempts between January 1, 2012, and December 31, 2018, were retrospectively included in this study.
Key secondary outcomes
(i) comparison of the RBO factors between the benign and malignant groups; (ii) resolution of the risk factors for RBO in the benign and malignant groups; and (iii) evaluation of the risk factors in each disease.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Consecutive patients with suspected hepatobiliary-pancreatic disorders who underwent EBD attempts were retrospectively included in this study.
2. Performance status; 0,1,2.
3. More than 20 years old.
4. All patients provided written informed consent to undergo EBD
Key exclusion criteria
Opt out method was adopted, and when the patients who underwent EBD reject to enrole in this study, the data will delete. The other drainage(i.e. pancreatic duct drainage, Duodenal stent) was also excleded.
Target sample size
2156
Research contact person
Name of lead principal investigator
| 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
TEL
03-3433-1111(3181)
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
TEL
03-3433-1111(2134)
Homepage URL
ccl09720@gmail.com
Sponsor or person
Institute
Department of Endoscopy, The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Endoscopy, 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
The Ethics committee of The Jikei University School of Medicine for Biomedical Research
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
Tel
03-3433-1111(2134)
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
31-099(9598)
Org. issuing International ID_1
The Ethics committee of The Jikei University School of Medicine for Biomedical Research
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-020-70081-3#citeas
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-020-70081-3#citeas
Number of participants that the trial has enrolled
2156
Results
Chiba, M., Kato, M., Kinoshita, Y. et al. Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis. Sci Rep 10, 13080 (2020). https://doi.org/10.1038/s41598-020-70081-3
Results date posted
| 2020 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 04 | Day |
Baseline Characteristics
Chiba, M., Kato, M., Kinoshita, Y. et al. Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis. Sci Rep 10, 13080 (2020). https://doi.org/10.1038/s41598-020-70081-3
Participant flow
Chiba, M., Kato, M., Kinoshita, Y. et al. Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis. Sci Rep 10, 13080 (2020). https://doi.org/10.1038/s41598-020-70081-3
Adverse events
Chiba, M., Kato, M., Kinoshita, Y. et al. Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis. Sci Rep 10, 13080 (2020). https://doi.org/10.1038/s41598-020-70081-3
Outcome measures
Chiba, M., Kato, M., Kinoshita, Y. et al. Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis. Sci Rep 10, 13080 (2020). https://doi.org/10.1038/s41598-020-70081-3
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
| 2019 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 04 | Day |
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 08 | Month | 04 | Day |
Other
Other related information
The present retrospective cohort study was investigated the period to recurrent biliary obstruction after plastic stent placement. This study complied with the TOKYO criteria 2014 for a time to event analysis and with the other guidelines on survival analyses
Management information
Registered date
| 2019 | Year | 08 | Month | 08 | Day |
Last modified on
| 2020 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042910
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