UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025760 |
|---|---|
| Receipt number | R000029636 |
| Scientific Title | Randomized controlled trial on efficacy of metal stents vs. inside plastic stents for unresectable malignant obstruction of the perihilar bile duct |
| Date of disclosure of the study information | 2017/02/24 |
| Last modified on | 2020/01/23 15:45:13 |
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Basic information
Public title
Randomized controlled trial on efficacy of metal stents vs. inside plastic stents
for unresectable malignant obstruction of the perihilar bile duct
Acronym
MiPS study
Scientific Title
Randomized controlled trial on efficacy of metal stents vs. inside plastic stents
for unresectable malignant obstruction of the perihilar bile duct
Scientific Title:Acronym
MiPS study
Region
| Japan |
Condition
Condition
Unresectable malignant perihilar biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of placement of inside plastic stents (PSs)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patency period of inside PSs
Key secondary outcomes
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
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Deployment of inside PSs
Interventions/Control_2
Deployment of metal stents (MSs)
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
a. those who have been diagnosed as malignant perihilar biliary obstruction with Bismuth level 2 or more.
b. Clinically non resectable
c. Total biliarubin =/> 2.0 mg/dL
d. No history of previous biliary stent placement
e. Expected prognosis > 3 months
f. Obtaining written informed concent
Key exclusion criteria
a. No tolerance of endoscopic procedures
b. ASA class 4 or more
c. Reconstructed upper GI tract
d. State after papillectomy, surgical biliojejunostomy
e. Planned for surgical resection, radiotherapy, PDT, or HIFU
f. Planned for scheduled replacement of PSs
g. State after placement of irremoval biliary stents
h. Tumors extending to lower bile duct
i. Tumors which have already invaded to broad area and which was considered to be difficult to treat with biliary drainage
j. Tumors with papillary growth
k. Active infectious inflammation
l. PSC, IgG4-SC and PBC
m. LC stage Child-Pugh C
n. Hemolyzing disease
o. Allergic for contrast
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yoshihide |
| Middle name | |
| Last name | Kanno |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9810913
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
TEL
022-252-1111
yoshi-hk@openhp.or.jp
Public contact
Name of contact person
| 1st name | Yoshihide |
| Middle name | |
| Last name | Kanno |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
981-0913
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
TEL
022-252-1111
Homepage URL
yoshi-hk@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
Sendai City Medical 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
Institutional Review Board of Sendai City Medical Center
Address
Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan
Tel
0222521111
yoshihk44@yahoo.co.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 | 02 | Month | 24 | 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 | 01 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 20 | Day |
Last modified on
| 2020 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029636
