UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027353 |
|---|---|
| Receipt number | R000030551 |
| Scientific Title | Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction: A prospective multicenter study |
| Date of disclosure of the study information | 2017/05/16 |
| Last modified on | 2020/05/19 02:12:41 |
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Basic information
Public title
Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction: A prospective multicenter study
Acronym
Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction : A prospective multicenter study(FCAP)
Scientific Title
Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction: A prospective multicenter study
Scientific Title:Acronym
Efficacy and safety of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction : A prospective multicenter study(FCAP)
Region
| Japan |
Condition
Condition
Unresectable hilar malignant biliary obstruction
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of endoscopic biliary stenting with fully covered self expanding metal stent for unresectable hilar malignant biliary obstruction
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Six month primary patency rate of fully covered self-expandable metal stent
Key secondary outcomes
safety, technical success rate, functional success rate, procedure time, stent patency period, cause of stent obstruction, death related endoscopic procedure, re-intervention rate, technical success rate of re-intervention, overall survival time
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Placement of fully covered self expanding metal stent for unresectable hilar malignant biliary obstruction
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
a) Unresectable hilar malignant biliary obstruction is proven by historical or pathological or radiological diagnosis
b) Obstruction of Bismuth type II or higher and before biliary drainage with metal stent
c) Effective biliary drainage already performed without metal stent
d) Patients of age>=20years
e) Life expectancy>=3months
f) Patients with written informed consent
Key exclusion criteria
a) Patients after gastrectomy without Billroth-I reconstruction
b) Patients with pancreatitis
c) Inappropriate patients for entry on this study in the judgement of the investigator
d) Patients who refused to entry this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoshi , Hirotsugu |
| Middle name | |
| Last name | Sugimori, Maruyama |
Organization
Osaka City University Graduate School of Medicine, Department of Gastroenterology
Division name
Gastroenterology
Zip code
5458586
Address
1-5-7, Asahi-chou, Abeno, Osaka, Osaka
TEL
06-6645-3811
m1151329@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke/ Hirotsugu |
| Middle name | |
| Last name | Kinoshita/ Maruyama |
Organization
Osaka City University Graduate School of Medicine, Department of Gastroenterology
Division name
Gastroenterology
Zip code
5458586
Address
1-5-7, Asahi-chou, Abeno, Osaka, Osaka
TEL
06-6645-3811
Homepage URL
yousukekino.13@gmail.com
Sponsor or person
Institute
Osaka City University Graduate School of Medicine, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Takarazuka City Hospital, Baba Memorial Hospital, Minamiosaka Hospital, Osaka City General Hospital, Osaka Prefecture Saiseikai Nakatsu Hospital, Ishikiriseiki Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Hospital Certified Review Board
Address
1-2-7-601, asahi-chou, abeno-ku, osaka, Osaka
Tel
06-6645-3456
ethics@med.osaka-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
大阪市立大学医学部附属病院(大阪府)、宝塚記念病院(大阪府)、馬場記念病院(大阪府)、南大阪病院(大阪府)、大阪市立総合医療センター(大阪府)、大阪府済生会中津病院(大阪府)、医療法人藤井会石切生喜病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 16 | 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
30
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
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate efficacy of endoscopic biliary stenting with fully covered self expandable metal stent for unresectable hilar malignant biliary obstruction
Management information
Registered date
| 2017 | Year | 05 | Month | 16 | Day |
Last modified on
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030551
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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| Registered date | File name |
