UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008494 |
|---|---|
| Receipt number | R000009986 |
| Scientific Title | Effect and safety of endoscopic treatment for acute mild and moderate cholangitis associated with common bile duct stones, a multicenter feasibility study. |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2015/01/22 13:36:48 |
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Basic information
Public title
Effect and safety of endoscopic treatment for acute mild and moderate cholangitis associated with common bile duct stones, a multicenter feasibility study.
Acronym
Effect and safety of endoscopic treatment for acute mild and moderate cholangitis associated with common bile duct stones, a multicenter feasibility study.
Scientific Title
Effect and safety of endoscopic treatment for acute mild and moderate cholangitis associated with common bile duct stones, a multicenter feasibility study.
Scientific Title:Acronym
Effect and safety of endoscopic treatment for acute mild and moderate cholangitis associated with common bile duct stones, a multicenter feasibility study.
Region
| Japan |
Condition
Condition
Acute mild and moderate cholangitis associated with common biliary stones.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a utility and safty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of days until improvement
Key secondary outcomes
Complication rates
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Mild and moderate acute cholangitis associated with common biliary stones in Tokyo Guideline.
2) Excluded bile duct stricture by US, EUS, CT or MRCP.
3) Intact papilla of vater.
4) A value of more than 3 in performance status according to the scale of the Eastern Cooperative Oncology Group.
5) Patients aged 20 years and older.
6) Patients with informed consent for joining the presesnt study
Key exclusion criteria
1) Sever acute cholangitis in Tokyo Guideline.
2) Malignant disease and biliary stricter by US, EUS, CT or MRCP.
3) Plt<50000, PT-INR>2.0
4) Acute pancreatitis
5) Ampullary neoplasm
6) Infiltration of the papillary area by pancreatic cancer
7) Billoth II gastrectomy, Roux-en-Y reconstruction
8) Anomalous pancreaticobiliary channel
9) Separate papillary orifices of the common bilie duct and pancreatic duct.
10) Choledochoduodenal Fisutula
11) A value of more than I-1 ipaired consiousness accoding to the scale of the Japan Coma Scale.
12) Severe heart disease
13) Severe pulmonary disease
14) Pregnant or lactating
15) Judged inappropriate by a doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi KAWAKAMI |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo 060-8638, Japan
TEL
011-716-1161
hiropon@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Midori Nishioka |
Organization
Hokkaido University Hospital
Division name
Clinical trial center
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo 060-8638, Japan
TEL
011-716-1161
Homepage URL
midorin@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
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
Address
Tel
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
| 2012 | Year | 08 | Month | 06 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 31 | Day |
Other
Other related information
Multicenter non-randomized and non-blinded exploratory clinical study
Management information
Registered date
| 2012 | Year | 07 | Month | 22 | Day |
Last modified on
| 2015 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009986
