UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030022 |
|---|---|
| Receipt number | R000033002 |
| Scientific Title | A novel metallic stent for unresectable distal malignant biliary obstruction; A multicenter prospective study |
| Date of disclosure of the study information | 2017/11/17 |
| Last modified on | 2022/05/13 11:12:23 |
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Basic information
Public title
A novel metallic stent for unresectable distal malignant biliary obstruction; A multicenter prospective study
Acronym
EVOLUTION study
Scientific Title
A novel metallic stent for unresectable distal malignant biliary obstruction; A multicenter prospective study
Scientific Title:Acronym
EVOLUTION study
Region
| Japan |
Condition
Condition
Unresectable distal malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of novel full covered metal stent for unresectable malignant distal biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Stent patency
Key secondary outcomes
Technical success, Clinical success, Complications, Stent replaced, Survival period
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Full covered self expandable metal stent
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 unresectable malignant biliary stricture diagnosed by pathological findings.
(2) Patients with written informed consent.
Key exclusion criteria
(1) Patients with uncontrolable jaundice or cholangitis after biliary drainage.
(2) Patients with serious comorbidities.
(3) Patients with ECOG performance status 4.
(4) Patients with not expected prognosis more than 3 months.
(5) Patients with hilar biliary stricture.
(6) Patients with biliary reconstruction.
(7) Patients with considered ineligible by the attending physician.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Masuda |
Organization
Kobe University Graduate School of Medicine
Division name
Division of gastroenterology, Department of Internal medicine
Zip code
650-0017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6305
atmasuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Arata |
| Middle name | |
| Last name | Sakai |
Organization
Kobe University Graduate School of Medicine
Division name
Division of gastroenterology, Department of Internal medicine
Zip code
650-0017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6305
Homepage URL
asakai@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kobe Univ. Hosp. clinical and translational research center
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel
078-382-6669
kainyu@med.kobe-u.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 17 | 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
73
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
| 2018 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 11 | Month | 20 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 17 | Day |
Last modified on
| 2022 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033002
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
