UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042079 |
|---|---|
| Receipt number | R000043307 |
| Scientific Title | A retrospective study on long-term outcome of gallbladder stent placement using nasobiliary drainage tube for acute cholecystitis |
| Date of disclosure of the study information | 2020/10/12 |
| Last modified on | 2020/10/11 17:12:51 |
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Basic information
Public title
A retrospective study on long-term outcome of gallbladder stent placement using nasobiliary drainage tube for acute cholecystitis
Acronym
A retrospective study on long-term outcome of gallbladder stent placement using nasobiliary drainage tube for acute cholecystitis
Scientific Title
A retrospective study on long-term outcome of gallbladder stent placement using nasobiliary drainage tube for acute cholecystitis
Scientific Title:Acronym
A retrospective study on long-term outcome of gallbladder stent placement using nasobiliary drainage tube for acute cholecystitis
Region
| Japan |
Condition
Condition
Acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the long-term prognosis of gallbladder stent placement using nasobiliary drainage tube (BLADE) performed in patients who had not undergone cholecystectomy for acute cholecystitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate of cholecystitis
Key secondary outcomes
The incidence of late adverse events, procedure success rate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent the BLADE procedure from April 2014 to December 2018 and did not perform cholecystectomy.
Key exclusion criteria
Patients who underwent BLADE procedure during the same period and performed cholecystectomy within 3 months.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinpei |
| Middle name | |
| Last name | Doi |
Organization
Teikyo University School of medicine University Mizonokuchi Hospital
Division name
Dept of Gastroenterology
Zip code
213-8507
Address
5-1-1, Futago, Takatsu-ku, Kawasaki city, Kanagawa pref
TEL
044-844-3333
sinpesan@gmail.com
Public contact
Name of contact person
| 1st name | Shinpei |
| Middle name | |
| Last name | Doi |
Organization
Teikyo University School of medicine University Mizonokuchi Hospital
Division name
Dept of Gastroenterology
Zip code
213-8507
Address
5-1-1, Futago, Takatsu-ku, Kawasaki city, Kanagawa pref
TEL
044-844-3333
Homepage URL
sinpesan@gmail.com
Sponsor or person
Institute
Teikyo University School of medicine University Mizonokuchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Teikyo University School of medicine University Mizonokuchi Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Ethics Committee Secretariat
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
Tel
03-3964-7256
turb-office@teikyo-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
帝京大学医学部附属溝口病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 12 | 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
50
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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data has been aggregated and analysis is in progress.
Management information
Registered date
| 2020 | Year | 10 | Month | 11 | Day |
Last modified on
| 2020 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043307
