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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008494
Receipt No. 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

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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
Email 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
Email midorin@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009986

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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