UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060016 |
|---|---|
| Receipt number | R000068206 |
| Scientific Title | Prospective multicenter cohort study of the clinical outcomes of endoscopic retrograde cholangiopancreatography (ERCP)-related procedures |
| Date of disclosure of the study information | 2025/12/08 |
| Last modified on | 2025/12/09 06:13:24 |
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Basic information
Public title
Research on the clinical outcomes of endoscopic retrograde cholangiopancreatography (ERCP)
Acronym
Research on ERCP
Scientific Title
Prospective multicenter cohort study of the clinical outcomes of endoscopic retrograde cholangiopancreatography (ERCP)-related procedures
Scientific Title:Acronym
Prospective multicenter cohort study of ERCP-related procedures
Region
| Japan |
Condition
Condition
Pancreatobiliary diseases
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the clinical outcomes of ERCP-related procedures and their prognostic factors.
Basic objectives2
Others
Basic objectives -Others
Patient factors include patient status (e.g., age, sex, vital signs, past medical history, family history, lifestyle factors, and comorbidities), blood tests, and imaging studies (e.g., radiology reports and imaging files) before and after ERCP, as well as ERCP-related procedures.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Short- and long-term outcomes of ERCP-related procedures and others
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 who undergo ERCP for diagnostic and therapeutic indications
Key exclusion criteria
Patients with missing data on the main exposure variable of a given analysis and those who refused to participate in this research
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Watanabe |
Organization
The Fraternity Memorial Hospital
Division name
Department of Gastroenterology
Zip code
130-8587
Address
2-1-11 Yokoami, Sumida City, Tokyo, Japan
TEL
0570-200-678
t_watanabe@douai.jp
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | Watanabe |
Organization
The Fraternity Memorial Hospital
Division name
Department of Gastroenterology
Zip code
130-8587
Address
2-1-11 Yokoami, Sumida City, Tokyo, Japan
TEL
0570-200-678
Homepage URL
t_watanabe@douai.jp
Sponsor or person
Institute
The Fraternity Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The Fraternity Memorial Hospital
Address
2-1-11 Yokoami, Sumida City, Tokyo, Japan
Tel
0570-200-678
mail@douai.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
日本赤十字社医療センター（東京都）、関東中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 08 | 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
| 2025 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2030 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will use follow-up data obtained during routine clinical care for patients after ERCP-related procedures.
Management information
Registered date
| 2025 | Year | 12 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068206
