UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017065 |
|---|---|
| Receipt number | 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 | 2020/04/10 13:29:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ctroffice@sakuhp.or.jp
Sponsor or person
Institute
Saku Central Hospital Advanced Care Center
Institute
Department
Personal name
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
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
Completed
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
| 2020 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019767
