UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040454 |
|---|---|
| Receipt number | R000046174 |
| Scientific Title | Endoscopic retrograde cholangiopancreatography (ERCP) using a short-type single-balloon enteroscope in patients with surgically altered gastrointestinal anatomy: A multicenter Retrospective study |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2025/11/22 10:36:52 |
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Basic information
Public title
Endoscopic retrograde cholangiopancreatography (ERCP) using a short-type single-balloon enteroscope in patients with surgically altered gastrointestinal anatomy: A multicenter Retrospective study
Acronym
Short-SBE assisted ERCP: A multicenter Retrospective study
Scientific Title
Endoscopic retrograde cholangiopancreatography (ERCP) using a short-type single-balloon enteroscope in patients with surgically altered gastrointestinal anatomy: A multicenter Retrospective study
Scientific Title:Acronym
Short-SBE assisted ERCP: A multicenter Retrospective study
Region
| Japan |
Condition
Condition
choledocholithiasis, Obstructive jaundice, malignant biliary obstruction, pancreatic duct stricture
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of short-SBE assisted ERCP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
enteroscopy success rate, biliary cannulation success rate, procedural success rate
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 surgically altered
anatomy who underwent ERCP-related
procedures between September 2011 and
August 2019.
Key exclusion criteria
When Patient hopes to Cancel the study,
When researcher judges that it is not appropriate case
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Tanisaka |
Organization
Saitama Medical University International Medical Center
Division name
Gastroenterology
Zip code
350-1298
Address
Yamane, Hidaka, Saitama 1397-1
TEL
042-984-4111
tanisaka1205@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Tanisaka |
Organization
Saitama Medical University International Medical Center
Division name
Gastroenterology
Zip code
350-1298
Address
Yamane, Hidaka, Saitama 1397-1
TEL
042-984-4111
Homepage URL
tanisaka1205@gmail.com
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center IRB center
Address
Yamane, Hidaka, Saitama 1397-1
Tel
042-984-4111
chikens@saitama-med.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
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.giejournal.org/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.giejournal.org/
Number of participants that the trial has enrolled
1318
Results
The total procedural success and adverse events rate among the first procedure in 1318 patients were 74.9% and 7.7%,respectively.
Results date posted
| 2025 | Year | 11 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent ERCP-related procedures using Short-SBE for surgically altered anatomy between September 1, 2011, and August 31, 2019
Participant flow
Because it was a retrospective study, case accumulation proceeded smoothly.
Adverse events
Adverse events rate was 7.7 % without any lethal.
Outcome measures
We retrospectively evaluated procedure success rate and adverse events rate.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cases will be accumulated after passing through IRB at each institution.
Management information
Registered date
| 2020 | Year | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046174
