UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056806 |
|---|---|
| Receipt number | R000064926 |
| Scientific Title | The impact of endoscopic sphincterotomy during endoscopic transpapillary biliary drainage for acute cholangitis with sepsis-induced coagulopathy |
| Date of disclosure of the study information | 2025/01/24 |
| Last modified on | 2025/01/24 12:37:50 |
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Basic information
Public title
The impact of endoscopic sphincterotomy during endoscopic transpapillary biliary drainage for acute cholangitis with sepsis-induced coagulopathy
Acronym
The impact of endoscopic sphincterotomy during endoscopic transpapillary biliary drainage for acute cholangitis with sepsis-induced coagulopathy
Scientific Title
The impact of endoscopic sphincterotomy during endoscopic transpapillary biliary drainage for acute cholangitis with sepsis-induced coagulopathy
Scientific Title:Acronym
The impact of endoscopic sphincterotomy during endoscopic transpapillary biliary drainage for acute cholangitis with sepsis-induced coagulopathy
Region
| Japan |
Condition
Condition
Patients with acute cholangitis with sepsis-induced coagulopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparison of procedure-related complications will be conducted between the two groups. The risk of bleeding with the addition of endoscopic sphincterotomy (EST) will be compared to the risk of pancreatitis without EST.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A comparison of procedure-related complications will be conducted between the two groups. The risk of bleeding with the addition of endoscopic sphincterotomy (EST) will be compared to the risk of pancreatitis without EST.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases of acute cholangitis with sepsis-induced coagulopathy treated with endoscopic transpapillary biliary drainage.
Key exclusion criteria
Cases with gastrointestinal reconstruction other than Billroth-I reconstruction.
Other cases deemed unsuitable as subjects by the principal investigator (or sub-investigator).
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1 Idaigaoka, Hasamacho, Yufu, Oita, Japan
TEL
097-586-6193
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita University
Division name
Department of Gastroenterology
Zip code
879-5593
Address
1-1 Idaigaoka, Hasamacho, Yufu, Oita, Japan
TEL
097-586-4193
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita University
Address
1-1 Idaigaoka, hasama-cho, Yufu, Oita, 8795593, Japan
Tel
097-586-6193
sagami1985@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 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 01 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064926
