UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033213 |
|---|---|
| Receipt number | R000037874 |
| Scientific Title | Usefulness of short term stent placement to prevent cholangitis after endoscopic therapy of common bile duct stone. |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2019/03/30 16:38:14 |
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Basic information
Public title
Usefulness of short term stent placement to prevent cholangitis after endoscopic therapy of common bile duct stone.
Acronym
short term stent placement after endoscopic therapy of common bile duct stone.
Scientific Title
Usefulness of short term stent placement to prevent cholangitis after endoscopic therapy of common bile duct stone.
Scientific Title:Acronym
short term stent placement after endoscopic therapy of common bile duct stone.
Region
| Japan |
Condition
Condition
common bile duct stone, cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness of short term stent placement to prevent cholangitis after endoscopic therapy of common bile duct stone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between stent placement and colangitis after endoscopic therapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with short term stent placement after endoscopic therapy of common bile duct stone.
Interventions/Control_2
Patients without short term stent placement after endoscopic therapy of common bile duct stone.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with common bile duct stone and/or cholangitis should be treated by endoscopic sphincterotomy and stone removal.
2. Patients with informed consent.
Key exclusion criteria
1. Patients with scheduled cholecystectomy.
2. Patients with sever cholangitis.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
New Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
270-2232
Address
1271 Wanagaya, Matsudo Chiba, Japan
TEL
0477118700
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
New Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
270-2232
Address
1271 Wanagaya, Matsudo Chiba, Japan
TEL
0477118700
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
New Tokyo Hospital
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
New Tokyo Hospital
Address
1271 Wanagaya, Matsudo Chiba, Japan
Tel
0477118700
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 | 06 | Month | 30 | 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 | 20 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | 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 | 06 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037874
