UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023347 |
|---|---|
| Receipt number | R000026904 |
| Scientific Title | A prospective study: the efficacy of tapered balloon catheter for endoscopic multiple biliary stenting in malignant hilar biliary stricture. |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2025/08/04 11:27:23 |
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Basic information
Public title
A prospective study: the efficacy of tapered balloon catheter for endoscopic multiple biliary stenting in malignant hilar biliary stricture.
Acronym
The efficacy of tapered balloon catheter for endoscopic multiple biliary stenting
Scientific Title
A prospective study: the efficacy of tapered balloon catheter for endoscopic multiple biliary stenting in malignant hilar biliary stricture.
Scientific Title:Acronym
The efficacy of tapered balloon catheter for endoscopic multiple biliary stenting
Region
| Japan |
Condition
Condition
malignant hilar biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To review the efficacy of tapered balloon catheter for endoscopic multiple biliary stenting in malignant biliary stricture patients who have already placed one or more metalic biliary stent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of procedure (placing the additional biliary stent, passing a mesh of metalic stent using tapered balloon catheter)
Key secondary outcomes
1. Safety (the rate or severity of adverse effects)
2. Improving hepatobiliary laboratory data one day after procedure.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using the tapered balloon catheter for endoscopic metalic biriary drainage
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
Malignant hilar biliary stricture patients who need multiple biliary drainage
Key exclusion criteria
1. Patients who are younger than 20 years old.
2. patients who present a difficult endoscopic approach due to gastrointestional obstruction.
3. Patients from whom informed concent cannot be obtained.
4. Patients who were performed abdominal surgery
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Ohira |
Organization
Fukushima Medical University
Division name
Gastroenterology
Zip code
960-1295
Address
1, Hikarigaoka, Fukushima City
TEL
024-547-1202
h-ohira@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Sugimoto |
Organization
Fukushima Medical University
Division name
Gastroenterology
Zip code
960-1295
Address
1, Hikarigaoka, Fukushima City
TEL
024-547-1202
Homepage URL
kita335@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
Tel
024-547-1111
rs@fmu.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
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000026904
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
45
Results
discontinuation
Results date posted
| 2025 | Year | 08 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Malignant hilar biliary stricture patients who need multiple biliary drainage
Participant flow
Obtain informed concent.
Adverse events
None
Outcome measures
Success rate of procedure (placing the additional biliary stent, passing a mesh of metalic stent using tapered balloon catheter)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2016 | Year | 07 | Month | 26 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026904
