UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054406 |
|---|---|
| Receipt number | R000062107 |
| Scientific Title | Diagnostic and Therapeutic Outcomes of Endoscopic Retrograde Cholangiopancreatography (ERCP) Related Procedures in Hepatopancreatobiliary Diseases -retrospective study- |
| Date of disclosure of the study information | 2024/05/15 |
| Last modified on | 2024/05/15 21:47:44 |
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Basic information
Public title
Retrospective study of diagnostic and therapeutic Outcomes of ERCP Related Procedures
Acronym
Retrospective study of ERCP
Scientific Title
Diagnostic and Therapeutic Outcomes of Endoscopic Retrograde Cholangiopancreatography (ERCP) Related Procedures in Hepatopancreatobiliary Diseases -retrospective study-
Scientific Title:Acronym
Diagnostic and Therapeutic Outcomes of ERCP Related Procedures in Hepatopancreatobiliary Diseases -retrospective study-
Region
| Japan |
Condition
Condition
Distal Malignant of Biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the occlusion and migration factors of SEMS (Self-Expanding Metal Stents) inserted via ERCP
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TRBO-related factors
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with SEMS placement for distal malignant biliary stricture
Key exclusion criteria
Patients in whom SEMS were placed using percutaneous transhepatic biliary drainage or endoscopic ultrasound-guided biliary drainage were excluded
Target sample size
119
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | Sudo |
Organization
Kimitsu Chuo Hospital
Division name
Gastroenterology
Zip code
292-0822
Address
1010 Sakurai, Kisarazu, Chiba, Japan
TEL
0438-36-1071
t_sudo@aol.com
Public contact
Name of contact person
| 1st name | Taiga |
| Middle name | |
| Last name | Sudo |
Organization
Kimitsu Chuo Hospital
Division name
Gastroenterology
Zip code
292-0822
Address
1010 Sakurai, Kisarazu, Chiba, Japan
TEL
0438-36-1071
Homepage URL
t_sudo@aol.com
Sponsor or person
Institute
Kimitsu Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kimitsu Chuo Hospital
Address
1010 Sakurai, Kisarazu, Chiba 292-0822, Japan
Tel
0438-36-1071
t_sudo@aol.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
| 2024 | Year | 05 | Month | 15 | 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
119
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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective study that referred to the database of patients treated with ERCP at our hospital.The database was used to search for risk factors.
Management information
Registered date
| 2024 | Year | 05 | Month | 15 | Day |
Last modified on
| 2024 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062107
