UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052575 |
|---|---|
| Receipt number | R000059994 |
| Scientific Title | One-stage versus Two-stage endoscopic management for acute cholangitis caused by common bile duct stones: A retrospective multicenter cohort study |
| Date of disclosure of the study information | 2023/10/24 |
| Last modified on | 2023/10/23 12:56:11 |
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Basic information
Public title
One-stage versus Two-stage endoscopic management for acute cholangitis caused by common bile duct stones: A retrospective multicenter cohort study
Acronym
One-stage versus Two-stage endoscopic management for acute cholangitis caused by common bile duct stones: A retrospective multicenter cohort study
Scientific Title
One-stage versus Two-stage endoscopic management for acute cholangitis caused by common bile duct stones: A retrospective multicenter cohort study
Scientific Title:Acronym
One-stage versus Two-stage endoscopic management for acute cholangitis caused by common bile duct stones: A retrospective multicenter cohort study
Region
| Japan |
Condition
Condition
acute cholangitis caused by common bile duct stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary outcomes were the technical and clinical success rate of the one- and two-stage group.
The secondary outcomes were early and late AEs of the two groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes were the technical and clinical success rate of the one- and two-stage group.
Key secondary outcomes
The secondary outcomes were early and late AEs of the two groups.
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) patients who underwent ERCP for the management of acute cholangitis caused by CBDS with a naive papilla
2) patients who had at least one follow-up after the procedure.
Key exclusion criteria
1) a prior history of endoscopic management of CBDS
2) a prior history of upper gastrointestinal or biliary tract surgery, except for gastrectomy with Billroth I reconstruction and cholecystectomy
3) presence of pancreatobiliary malignancies
4) presence of bile duct stricture, including primary sclerosing cholangitis
5) unsuccessful ERCP and convert to percutaneous transhepatic biliary drainage (PTBD) or endoscopic ultrasound-rendezvous (EUS-RV)
Target sample size
570
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Maruta |
Organization
Gifu Prefectural General Medical Center
Division name
Department of Gastroenterology
Zip code
500-8717
Address
4-6-1 Noisshiki, Gifu City, Gifu Prefecture
TEL
0582461111
mrak5844@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Maruta |
Organization
Gifu Prefectural General Medical Center
Division name
Department of Gastroenterology
Zip code
500-8717
Address
4-6-1 Noisshiki, Gifu City, Gifu Prefecture
TEL
0582461111
Homepage URL
mrak5844@yahoo.co.jp
Sponsor or person
Institute
Gifu Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Gifu Prefectural General Medical Center
Address
4-6-1 Noisshiki, Gifu City, Gifu Prefecture
Tel
0582461111
mrak5844@yahoo.co.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
| 2023 | Year | 10 | Month | 24 | 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
577
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
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The database analysis was then performed between May 2010 and December 2020.
Management information
Registered date
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2023 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059994
