UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056742 |
|---|---|
| Receipt number | R000064844 |
| Scientific Title | Minimal endoscopic sphincterotomy with balloon dilation versus sphincterotomy alone, endoscopic management of common bile duct stones: A propensity score-based cohort analysis. |
| Date of disclosure of the study information | 2025/01/17 |
| Last modified on | 2025/01/17 14:02:32 |
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Basic information
Public title
Minimal endoscopic sphincterotomy with balloon dilation versus sphincterotomy alone, endoscopic management of common bile duct stones: A propensity score-based cohort analysis.
Acronym
ESBD vs EST
Scientific Title
Minimal endoscopic sphincterotomy with balloon dilation versus sphincterotomy alone, endoscopic management of common bile duct stones: A propensity score-based cohort analysis.
Scientific Title:Acronym
ESBD vs EST
Region
| Japan |
Condition
Condition
common bile duct stone
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the stone removal rate, safety, and long-term prognosis of ESBD and EST for CBDS, using a propensity score-based cohort analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Early adverse events of the EST and ESBD group.
Key secondary outcomes
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
Patients who underwent successful ESBD or EST for the management of CBDS
Key exclusion criteria
1) a prior history of papillary intervention
2) patients who underwent ERCP for CBDS after upper gastrointestinal or biliary tract surgery, except for gastrectomy with Billroth I reconstruction and cholecystectomy
3) patients who performed two-stage endoscopic management in which only biliary drainage is performed in the initial ERCP, and papillary procedure and stone extraction are performed in the second sessionpatients who underwent endoscopic ultrasound rendezvous (EUS-RV) for bile duct cannulation
4) patients with gallstone pancreatitis
5) patients who underwent endoscopic ultrasound rendezvous (EUS-RV) for bile duct cannulation
6) presence of upper gastrointestinal or pancreatobiliary malignancies.
Target sample size
1000
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
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
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
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
| 2025 | Year | 01 | Month | 17 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Eligible cases will be collected and a retrospective study will be conducted.
Management information
Registered date
| 2025 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064844
