UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060060 |
|---|---|
| Receipt number | R000068686 |
| Scientific Title | Prospective study of suprapapillary double-layered plastic stent placement for unresectable malignant hilar biliary obstruction |
| Date of disclosure of the study information | 2025/12/29 |
| Last modified on | 2025/12/11 23:35:43 |
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Basic information
Public title
Prospective study of suprapapillary double-layered plastic stent placement for unresectable malignant hilar biliary obstruction
Acronym
Prospective study of suprapapillary double-layered plastic stent placement for unresectable malignant hilar biliary obstruction
Scientific Title
Prospective study of suprapapillary double-layered plastic stent placement for unresectable malignant hilar biliary obstruction
Scientific Title:Acronym
Prospective study of suprapapillary double-layered plastic stent placement for unresectable malignant hilar biliary obstruction
Region
| Japan |
Condition
Condition
unresectable malignant hilar biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the efficacy of suprapapillary double-layered plastic stent placement for unresectable malignant hilar biliary obstruction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time to recurrent biliary obstruction
Key secondary outcomes
Causes of recurrence of biliary obstruction (RBO)
Technical success rate
Clinical success rate
Rate of early adverse events
Rate of late adverse events other than RBO
Survival period
Feasibility and success rate of reintervention in case of RBO
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent the first biliary drainage with a permanent stent for unresectable malignant hilar biliary obstruction classified as Bismuth type I-III
Key exclusion criteria
1) Patients who had undergone upper gastrointestinal reconstruction other than Billroth I
2) Patients after bilioenteric anastomosis
3) Patients in whom clinical success is not expected by stent placement
4) Patients with temporary biliary drainage
5) Patients with transpapillary biliary stent placement and biliary-enteric anastomosis
6) Patients undergoing tumor ablation for biliary stricture
7) Patients with history or presence of benign biliary stricture
8) Pregnant patients
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Toji |
| Middle name | |
| Last name | Murabayashi |
Organization
Ise Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
516-8512
Address
1-471-2, Funae, Ise, Mie
TEL
0596-28-2171
murabayashitoji@m2.gmobb.jp
Public contact
Name of contact person
| 1st name | Toji |
| Middle name | |
| Last name | Murabayashi |
Organization
Ise Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
516-8512
Address
1-471-2, Funae, Ise, Mie
TEL
0596-28-2171
Homepage URL
murabayashitoji@m2.gmobb.jp
Sponsor or person
Institute
Ise Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Ise Red Cross Hospital
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 Ise Red Cross Hospital
Address
1-471-2, Funae, Ise, Mie
Tel
0596-28-2171
jimubu@ise.jrc.or.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
伊勢赤十字病院
静岡県立総合病院
福井県立病院
松阪中央総合病院
三重大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2028 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2029 | Year | 06 | Month | 30 | Day |
Other
Other related information
Multicenter prospective study
Ise Red Cross Hospital
Shizuoka General Hospital
Fukui Prefectural Hospital
Matusaka Chuo General Hospital
Mie University Hospital
Management information
Registered date
| 2025 | Year | 12 | Month | 11 | Day |
Last modified on
| 2025 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068686
