UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056891 |
|---|---|
| Receipt number | R000065024 |
| Scientific Title | Safety Performance and Contributing Factors in Emergency Endoscopic Bile Duct Drainage During the Mid-Night Hours, Multicenter Observational Study |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/01/31 16:31:07 |
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Basic information
Public title
Safety Performance and Contributing Factors in Emergency Endoscopic Bile Duct Drainage During the Mid-Night Hours
Acronym
Mid-night ERC study
Scientific Title
Safety Performance and Contributing Factors in Emergency Endoscopic Bile Duct Drainage During the Mid-Night Hours, Multicenter Observational Study
Scientific Title:Acronym
Mid-night ERC study
Region
| Japan |
Condition
Condition
Acute cholangitis, stone pancreatitis, acute cholecystitis, post-operative bile leakage, acute hemobilia
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the efficacy and safety of endoscopic biliary drainage performed urgently during the mid-night hours (10 p.m. to 5 a.m.) and factors that contribute to its safe implementation.Comparison between two groups: a late-night group (10 p.m. to 5 a.m.) and a non-late-night group (other than the hours shown on the left).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse event within two hospital days after endoscopic biliary drainage
Key secondary outcomes
1. Severity of adverse event
2. Incidence of intraoperative event
3. Success rate of bile duct cannulation and the time required
4. Total procedure time
5. Procedure completion rate
6. Procedure background and characteristics
7. Operator background and characteristics
8. Clinical success rate
9. Post-procedure hospitalization period
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. From April 1, 2021 to March 31, 2025, Patients with the following biliary emergencies who require urgent EBD.
2. Acute cholangitis, stone pancreatitis, acute cholecystitis, post-operative bile leakage, acute hemobilia
3. Age 18 years or older.
4. The subject or his/her representative has not expressed any refusal to participate in this study.
Key exclusion criteria
1. Patients with postoperative altered anatomy other than Billroth I.
2. Patients who mainly underwent pacreatic duct drainage.
3. Non-urgent endoscopic biliary drainage
4. Patients whose required information cannot be verified in the medical record.
5. Patients deemed inappropriate by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Kato |
Organization
National Hospital Organization, Hokkaido Medical Center
Division name
Department of Gastroenterology
Zip code
063-0005
Address
5-7, Yamanote, Nishi-ku, Sapporo, Japan
TEL
011-611-8111
shinchan1231@gmail.com
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Kato |
Organization
National Hospital Organization, Hokkaido Medical Center
Division name
Department of Gastroenterology
Zip code
063-0005
Address
5-7, Yamanote, Nishi-ku, Sapporo, Japan
TEL
011-611-8111
Homepage URL
shinchan1231@gmail.com
Sponsor or person
Institute
National Hospital Organization, Hokkaido Medical Center
Institute
Department
Personal name
Funding Source
Organization
self-funded
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
National Hospital Organization, Hokkaido Medical Center
Address
5-7, Yamanote, Nishi-ku, Sapporo, Japan
Tel
011-611-8111
shinchan1231@gmail.com
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 | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2025 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065024
