UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061805 |
|---|---|
| Receipt number | R000070725 |
| Scientific Title | A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction |
| Date of disclosure of the study information | 2026/06/05 |
| Last modified on | 2026/06/04 20:50:00 |
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Basic information
Public title
A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Acronym
A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Scientific Title
A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Scientific Title:Acronym
A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Region
| Japan |
Condition
Condition
Malignant hilar biliary obstruction case
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of double-layered inside plastic stents for unresectable malignant hilar biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stent patency duration and stent occlusion rates at 30, 60, and 90 days.
Key secondary outcomes
Technical and clinical success rates of stent placement
Adverse events associated with stent placement
Overall survival
Details of reintervention at the time of stent occlusion
Stent removal success rate
Types of stents used during reintervention, and technical and clinical success rates of reintervention
Stent patency duration after reintervention
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
Inside plastic stent placement for malignant hilar bile duct 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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with unresectable malignant hilar biliary obstruction
Patients with a pathological diagnosis of malignancy
Patients requiring biliary drainage due to abnormal values in any of the following: serum total bilirubin, AST, ALT, ALP, or g-GTP
The criteria for abnormal values are as follows
Total bilirubin more than 2 mg/dL
AST more than 45 IU/L
ALT more than 45 IU/L
ALP more than 170 IU/L
g-GTP more than 75 IU/L
Patients undergoing initial bilateral inside plastic stent placement
Patients expected to have a prognosis of at least 2 months
Patients with Bismuth type II-IV (requiring bilateral biliary drainage)
Age more than 18 years
Key exclusion criteria
Patients with concomitant distal biliary obstruction
Patients with surgically altered anatomy (excluding Billroth I reconstruction)
Patients with severe comorbidities affecting other organs
Patients in whom biliary cannulation (transpapillary approach) is not feasible
Patients with concomitant duodenal obstruction
ECOG performance status 4
Patients deemed unsuitable by the treating physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Matsunami General Hospital
Division name
Department of Gastroenterology
Zip code
501-6062
Address
Dendai 185-1, Kasamatsu-cho, Hashima-gun, Gifu 501-6062, Japan
TEL
058-388-0111
mkobdkl@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Matsunaimi general hospital
Division name
Department of Gastroenterology
Zip code
501-6062
Address
Dendai 185-1, Kasamatsu-cho, Hashima-gun, Gifu 501-6062, Japan
TEL
058-388-0111
Homepage URL
mkobdkl@yahoo.co.jp
Sponsor or person
Institute
Other
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
Gifu university hospital
Address
1-1 Yanagido, Gifu City 501-1194,JAPAN
Tel
058-230-6000
mkobdkl@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
| 2026 | Year | 06 | Month | 05 | 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
| 2026 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2031 | Year | 12 | 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
| 2026 | Year | 06 | Month | 04 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070725
