UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044975 |
|---|---|
| Receipt number | R000051388 |
| Scientific Title | Multicenter retrospective study to evaluate the prognosis and changes in liver function after endoscopic drainage therapy in cirrhotic patients with acute cholangitis |
| Date of disclosure of the study information | 2021/07/28 |
| Last modified on | 2021/07/28 00:52:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter retrospective study to evaluate the prognosis and changes in liver function after endoscopic drainage therapy in cirrhotic patients with acute cholangitis
Acronym
Multicenter retrospective study to evaluate the prognosis and changes in liver function after endoscopic drainage therapy in cirrhotic patients with acute cholangitis
Scientific Title
Multicenter retrospective study to evaluate the prognosis and changes in liver function after endoscopic drainage therapy in cirrhotic patients with acute cholangitis
Scientific Title:Acronym
Multicenter retrospective study to evaluate the prognosis and changes in liver function after endoscopic drainage therapy in cirrhotic patients with acute cholangitis
Region
| Japan |
Condition
Condition
Choledocholithiasis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the prognosis after endoscopic biliary drainage for choledocholithiasis in cirrhotic and non-cirrhotic patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-day mortality rate
Key secondary outcomes
Total-bilirubin recovery 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated endoscopically for choledocholithiasis
Key exclusion criteria
Patients who refused to participate in this study
Patients who had undergone percutaneous drainage before endoscopic treatment
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Graduate School of Medicine, Chiba University
Division name
Gastroenterology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
kato.naoya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Yasui |
Organization
Graduate School of Medicine, Chiba University
Division name
Gastroenterology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
Homepage URL
yasui_s@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Chiba University Graduate School
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
inohana-rinri@chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 28 | 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
699
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
| 2020 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 23 | 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
retrospective cohort study
Patients with choledocholithiasis who underwent endoscopic biliary drainage at Chiba University Hospital and Eastern Chiba Medical Center between January 2004 and December 2019
Management information
Registered date
| 2021 | Year | 07 | Month | 28 | Day |
Last modified on
| 2021 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051388
