UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032608 |
|---|---|
| Receipt number | R000036995 |
| Scientific Title | Usefulness of endoscopic ultrasound diagnosis of remnant stone to remove biliary stent after therapy of common bile duct stone and cholecystectomy. |
| Date of disclosure of the study information | 2018/05/16 |
| Last modified on | 2020/05/18 09:04:56 |
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Basic information
Public title
Usefulness of endoscopic ultrasound diagnosis of remnant stone to remove biliary stent after therapy of common bile duct stone and cholecystectomy.
Acronym
Detection of remnant stone of common bile duct by endoscopic ultrasound.
Scientific Title
Usefulness of endoscopic ultrasound diagnosis of remnant stone to remove biliary stent after therapy of common bile duct stone and cholecystectomy.
Scientific Title:Acronym
Detection of remnant stone of common bile duct by endoscopic ultrasound.
Region
| Japan |
Condition
Condition
common bile duct stone
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detection of remnant bile duct stone by EUS when stent removal after endoscopic therapy of bile duct stone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of remnant bile duct stone by EUS when stent removal and stone removal.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Evaluate remnant stone by EUS when stentis removal.
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
| 20 | years-old | <= |
Age-upper limit
| 98 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients performed endoscopic bile duct stone removal and stent placement for bile duct stone or choledocholithic cholangitis.
Key exclusion criteria
Patients who are pregnant or have a possibility of pregnancy.
Patients who disagree informed consent.
Patient judged by doctor as inappropriate as subject participant of study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita San-ai Medical Center
Division name
Department of Gastroenterology
Zip code
870-1151
Address
1213, Oaza Ichi, Oita, Oita 870-1151, Japan.
TEL
+81-97-541-1311
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita San-ai Medical Center
Division name
Department of Gastroenterology
Zip code
870-1151
Address
1213, Oaza Ichi, Oita, Oita 870-1151, Japan.
TEL
+81-97-541-1311
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
Oita San-ai Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Oita San-ai Medical Center
Address
1213, Oaza Ichi, Oita, Oita 870-1151, Japan.
Tel
+81-97-541-1311
sagami1985@yahoo.co.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
| 2018 | Year | 05 | Month | 16 | 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
| 2018 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 16 | Day |
Last modified on
| 2020 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036995
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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