UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016010 |
|---|---|
| Receipt number | R000018382 |
| Scientific Title | A prospective randomized controlled study of "one-step" vs "two-step" self-expandable metallic stent placement for the management of distal biliary obstruction by unresectable pancreatic cancer. |
| Date of disclosure of the study information | 2014/12/19 |
| Last modified on | 2020/12/24 18:27:57 |
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Basic information
Public title
A prospective randomized controlled study of "one-step" vs "two-step" self-expandable metallic stent placement for the management of distal biliary obstruction by unresectable pancreatic cancer.
Acronym
A prospective randomized controlled study of "one-step" vs "two-step" self-expandable metallic stent placement for the management of distal biliary obstruction by unresectable pancreatic cancer.
Scientific Title
A prospective randomized controlled study of "one-step" vs "two-step" self-expandable metallic stent placement for the management of distal biliary obstruction by unresectable pancreatic cancer.
Scientific Title:Acronym
A prospective randomized controlled study of "one-step" vs "two-step" self-expandable metallic stent placement for the management of distal biliary obstruction by unresectable pancreatic cancer.
Region
| Japan |
Condition
Condition
Distal biliary obstruction caused by unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of one-step and two-step self-expandable metallic stent(SEMS) placement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Time to SEMS dysfunction
Key secondary outcomes
Early(within 30 days after SEMS placement) and late complication, Overall survival, Bilirubin level decreasing rate, Total costs of SEMS-related interventions
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 considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
one-step SEMS placement
Interventions/Control_2
two-step SEMS placement
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)Written informed consent obtained
2)Age over 20 years old
3)Distal biliary obstruction with no history of biliary drainage caused by pancreatic cancer
4)Confirmation of unresectable pancreatic cancer
5)Endoscopic transpapillary SEMS placement
Key exclusion criteria
1)Prognosis will be within 30 days
2)Having post gastrectomy with Billoth II or Roux-en-Y reconstruction
3)After percutaneous biliary drainage
4)Having history of SEMS placement for biliary obstruction
5)Having active infectious disease except acute cholangitis
6)Having severe acute cholangitis according to Tokyo Guidelines
7)Patients with the allergy to metal
8)Pregnant women or those suspected of pregnancy
9)Patients considered ineligible by attending physicians
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Itaru |
| Middle name | |
| Last name | Naitoh |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya 467-8601, Japan
TEL
052-853-8211
inaito@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Itaru |
| Middle name | |
| Last name | Naitoh |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya 467-8601, Japan
TEL
052-853-8211
Homepage URL
inaito@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Hospital Clinical Research Review Board
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
052-858-7215
clinical_research@med.nagoya-cu.ac.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
岐阜県立多治見病院（岐阜県）、八事第二赤十字病院（愛知県）、春日井市民病院（愛知県）、名古屋市西部医療センター（愛知県）、豊川市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 19 | 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
90
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
| 2014 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 13 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 13 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 13 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 19 | Day |
Last modified on
| 2020 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018382
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