UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037640
Receipt No. 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 (Ver. 4)

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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)
Email 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
Email ccl09720@gmail.com

Sponsor
Institute Department of Endoscopy, The Jikei University School of Medicine
Institute
Department

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)
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042910