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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027599
Receipt No. R000031198
Scientific Title Efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stenting: Multicenter prospective observational study
Date of disclosure of the study information 2017/06/01
Last modified on 2017/06/01

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Basic information
Public title Efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stenting: Multicenter prospective observational study
Acronym Efficacy of inside metallic stent for benign biliary stricture
Scientific Title Efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stenting: Multicenter prospective observational study
Scientific Title:Acronym Efficacy of inside metallic stent for benign biliary stricture
Region
Japan

Condition
Condition Benign biliary stricture
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stent placement.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of stricture resolution at metallic stent removal after 4 month stent placement
Key secondary outcomes 1.Success rate of stent placement
2.Success rate of stent removal
3. Rate of stricture recurrence
4. Adverse events

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.Patients with refractory benign biliary strictures (Resolution of stricture was not achieved by plastic stent treatment).
2.Malignancy is ruled out by pathological examination and clinical course.
3.Biliary stricture was completely existed on ERC findings, or no flow of contrast material into the downstream within 60 seconds, if stenosis was incomplete.
4.Biliary strictures located above the ampulla 15 mm or more upstream.(Metallic stent could be placed inside the bile duct )
Key exclusion criteria 1.Patients with performance status 3 or 4
2.Patients with severe complications to other organs.
3.Stricture of intrahepatic bile duct
4.Age<20
5.Patients without informed concent
6.The size of bile duct size showed less than 8 mm on first ERC finding.
7.Patients with severe coagulation dysfunction.
8.Patients with hepaticojejunostomy
9.Patients judged inappropriate by chief medical examiner.
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hironari Kato
Organization Okayama University Hospital
Division name Department of Gastroenterology
Zip code
Address 2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL 086-235-7219
Email drkatocha@yahoo.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kazuyuki Matsumoto
Organization Okayama University Hospital
Division name Department of Endoscopy
Zip code
Address 2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL 086-235-7219
Homepage URL
Email matsumotokazuyuki0227@yahoo.co.jp

Sponsor
Institute Okayama University Hospital
Department of Gastroenterology
Institute
Department

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
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
2017 Year 06 Month 01 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
2017 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation period: 12 month(after metallic stent removal)

Management information
Registered date
2017 Year 06 Month 01 Day
Last modified on
2017 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031198

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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