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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017065
Receipt No. R000019767
Scientific Title Randomized controlled trial of endoscopic biliary drainage in patients with unresectable malignant distal biliary obstruction: transpapillary route vs. transenteric route
Date of disclosure of the study information 2015/04/08
Last modified on 2019/04/09

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Basic information
Public title Randomized controlled trial of endoscopic biliary drainage in patients with unresectable malignant distal biliary obstruction: transpapillary route vs. transenteric route
Acronym Randomized controlled trial of endoscopic biliary drainage in patients with unresectable malignant distal biliary obstruction: transpapillary route vs. transenteric route
Scientific Title Randomized controlled trial of endoscopic biliary drainage in patients with unresectable malignant distal biliary obstruction: transpapillary route vs. transenteric route
Scientific Title:Acronym Randomized controlled trial of endoscopic biliary drainage in patients with unresectable malignant distal biliary obstruction: transpapillary route vs. transenteric route
Region
Japan

Condition
Condition unresectable malignant distal biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the safety and efficacy between transenteric and transpapillary biliary draiange for unresectable malignant distal biliary obstruction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes technical success rate, clinical success rate, complications
Key secondary outcomes stent patency

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Transenteric biliary drainage; TEBD
Interventions/Control_2 Transpapillary biliary drainage; TPBD
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Malignant tumor with no indication of surgical operation
2) Necessity of biliary draianage
3) Written, signed consent for trial participation must be obtained from the patient or proxies.
Key exclusion criteria 1) Obstruction of intrahepatic bile duct
2) Difficulty of endoscopic procedure
3) Severe complications in other organs
4) Other problem(s) in the opinion of the Investigator(s).
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Hisa
Organization Saku Central Hospital Advanced Care Center
Division name Gastrointestinal medicine
Zip code 385-0051
Address 3400-28 Nakagomi, Saku, JAPAN
TEL 0267-62-8181
Email hisa.takeshi@sakuhp.or.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Hisa
Organization Saku Central Hospital Advanced Care Center
Division name Gastrointestinal medicine
Zip code 385-0051
Address 3400-28 Nakagomi, Saku, JAPAN
TEL 0267-62-8181
Homepage URL
Email ctroffice@sakuhp.or.jp

Sponsor
Institute Saku Central Hospital Advanced Care Center
Institute
Department

Funding Source
Organization Saku Central Hospital Advanced Care Center
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 Saku Central Hospital Group Research Ethics Committee
Address 197 Usuda, Saku, 384-0301 JAPAN
Tel 0267-82-3131
Email ctroffice@sakuhp.or.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 佐久総合病院佐久医療センター(長野県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 08 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 14
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 No longer recruiting
Date of protocol fixation
2015 Year 01 Month 07 Day
Date of IRB
2015 Year 01 Month 26 Day
Anticipated trial start date
2015 Year 03 Month 04 Day
Last follow-up date
2019 Year 12 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
2015 Year 04 Month 07 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019767

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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