UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053055 |
|---|---|
| Receipt number | R000059702 |
| Scientific Title | Frequency of adverse event of endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilatation (EPBD) for naive papilla in hemodialysis patients with common bile duct stones (A multicenter prospective study) |
| Date of disclosure of the study information | 2023/12/11 |
| Last modified on | 2023/12/11 12:48:48 |
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Basic information
Public title
Frequency of adverse event of endoscopic sphincterotomy or endoscopic papillary balloon dilatation for naive papilla in hemodialysis patients with common bile duct stones (A multicenter prospective study)
Acronym
A multicenter prospective study of adverse event rate of EST/EPBD in hemodialysis patients with common bile duct stones
Scientific Title
Frequency of adverse event of endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilatation (EPBD) for naive papilla in hemodialysis patients with common bile duct stones (A multicenter prospective study)
Scientific Title:Acronym
A multicenter prospective study of adverse event rate of EST/EPBD in hemodialysis patients with common bile duct stones
Region
| Japan |
Condition
Condition
Maintenance hemodialysis patients with naive papilla and with common bile duct stones
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospective assessment of adverse event rates of endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilatation (EPBD) in patients with untreated papilla, common bile duct stones and maintenance hemodialysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency and severity of bleeding and pancreatitis post procedure in whole hemodialysis patients with common bile duct stones
Key secondary outcomes
1.The frequency and severity of bleeding and pancreatitis post procedure in hemodialysis patients with common bile duct stones performing EST or with EPBD, respectively
2.The frequency and severity of ERCP-related adverse events other than bleeding and pancreatitis post procedure in whole hemodialysis patients with common bile duct stones
3.The factors associated with bleeding in maintenance hemodialysis patients
4. The factors associated with pancreatitis post procedure in maintenance hemodialysis patients
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with untreated papilla (patients without previous EST or EPBD)
Patients over 18 years-old at the time of entry
Patients who have provided written consent for participation
Key exclusion criteria
Patients who have undergone EST or EPBD.
Patients who cannot switch to Nafamostat as the anticoagulant for hemodialysis fluid.
Patients judged by study investigator/subinvestigators as inappropriate ones
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of medicine
Division name
Gastroenterology and Hepatology
Zip code
5650871
Address
Yamada-oka 2-2, Suita, Osaka, Japan
TEL
0668793621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Shigekawa |
Organization
Osaka University Graduate School of medicine
Division name
Gastroenterology and Hepatology
Zip code
5650871
Address
Yamada-oka 2-2, Suita, Osaka, Japan
TEL
0668793621
Homepage URL
m-shigekawa@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of medicine, department od Gastroenterology and Hepatology
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
Osaka University Hospital Institutional Review Board
Address
Yamadaoka 2-2, Suita, Osaka, Japan
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.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
| 2023 | Year | 12 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, prospective observational study
Management information
Registered date
| 2023 | Year | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059702
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| Registered date | File name |
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