UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059684 |
|---|---|
| Receipt number | R000068264 |
| Scientific Title | An observational study for efficacy and safety of endoscopic retrograde cholangiopancreatography |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/07 13:40:06 |
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Basic information
Public title
An observational study for efficacy and safety of endoscopic retrograde cholangiopancreatography
Acronym
An observational study for efficacy and safety of ERCP
Scientific Title
An observational study for efficacy and safety of endoscopic retrograde cholangiopancreatography
Scientific Title:Acronym
An observational study for efficacy and safety of ERCP
Region
| Japan |
Condition
Condition
Pancreatobiliary diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To cralify efficacy and safety of endoscopic retrograde cholangiopancreatography (ERCP) related procedures
Basic objectives2
Others
Basic objectives -Others
Procedure details of ERCP
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Test and therapeutic results of ERCP related procedures
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
Cases who underwent ERCP related procedures
Key exclusion criteria
None
Target sample size
9650
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Sugimoto |
Organization
Fukushima Medical University
Division name
Department of Gastroenterology, School of Medicine
Zip code
960-1295
Address
Hikarigaoka1, Fukushima City, Fukushima Prefecture, Japan
TEL
+81-24-547-1202
intmed2@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Sugimoto |
Organization
Fukushima Medical Univerisity
Division name
Department of Gastroenterology, School of Medicine
Zip code
960-1295
Address
Hikarigaoka1, Fukushima City, Fukushima Prefecture, Japan
TEL
+81-24-547-1202
Homepage URL
kita335@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukushima Rosai Hospital, Saiseikai Fukushima General Hospital, Ohtanishinouchi Hospital, Fukushima Red Cross Hospital, Soma General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
Hikarigaoka1, Fukushima City, Fukushima Prefecture
Tel
+81-24-547-1825
rs@fmu.ac.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 | 11 | Month | 07 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2031 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2031 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 07 | Month | 31 | Day |
Other
Other related information
ERCP related procedures are as follows,
ERC: Endoscopic retrograde cholangiography
ERP: Endoscopic retrograde pancreatography
EST: Endoscopic sphincterotomy
EPBD: Endoscopic papillary balloon dilatation
EPLBD: Endoscopic papillary large balloon dilation
EML: Endoscopic Mechanical Lithotripsy
EHL: Electro-hydraulic Lithotripsy
ERBD: Endoscopic retrograde biliary drainage
ENBD: Endoscopic nasobiliary drainage
ERGBD: Endoscopic retrograde gallbladder drainage
ENGBD: Endoscopic nasogallbladder drainage
ENPD: Endoscopic nasopancreatic drainage
ERPD: Endoscopic retrograde pancreatic drainage
EPS: Endoscopic pancreatic stenting
POCS: Peroral cholangioscopy
POPS: Peroral pancreatoscopy
IDUS: Intraductal ultrasonography
or, etc.
Management information
Registered date
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068264
