UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061426 |
|---|---|
| Receipt number | R000070254 |
| Scientific Title | Efficacy and safety of EUS-guided hepaticoduodenostomy for unresectable malignant hilar biliary obstruction: A multicenter retrospective study using propensity score matching |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/05/01 00:24:25 |
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Basic information
Public title
Efficacy and safety of EUS-guided hepaticoduodenostomy for unresectable malignant hilar biliary obstruction: A multicenter retrospective study using propensity score matching
Acronym
Efficacy and safety of EUS-guided hepaticoduodenostomy for unresectable malignant hilar biliary obstruction: A multicenter retrospective study using propensity score matching
Scientific Title
Efficacy and safety of EUS-guided hepaticoduodenostomy for unresectable malignant hilar biliary obstruction: A multicenter retrospective study using propensity score matching
Scientific Title:Acronym
Efficacy and safety of EUS-guided hepaticoduodenostomy for unresectable malignant hilar biliary obstruction: A multicenter retrospective study using propensity score matching
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 retrospectively investigate the technical and clinical success, safety profile, time to recurrent biliary obstruction (TRBO), and re-intervention success of EUS-HDS in patients with unresectable MHBO.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success rate and clinical success rate
Key secondary outcomes
Adverse events (AEs), recurrent biliary obstruction (RBO), time to RBO (TRBO), re-intervention success rate, and overall survival (OS).
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
Cohort 1(Single-arm analysis):
Patients who underwent EUS-HDS for unresectable malignant hilar biliary obstruction (MHBO) between January 2015 and April 2026.
Cohort 2 (Comparative analysis):
Patients who underwent either EUS-HDS or EUS-HGS for unresectable MHBO between January 2015 and April 2026.
Key exclusion criteria
General exclusion criteria (for both cohorts):
1) Benign biliary strictures.
2) Malignant biliary strictures resulting from postoperative anastomotic recurrence.
3) Bismuth type I malignant hilar biliary obstruction (MHBO).
Specific exclusion criteria for Cohort 2 (Comparative analysis):
1) Cases involving EUS-guided biliary drainage (EUS-BD) with bridging stenting.
2) Cases in which both EUS-HDS and EUS-HGS were performed within 14 days.
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Okusaka |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
tokusaka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Soma |
| Middle name | |
| Last name | Fukuda |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
sofukud@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Japan
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Japan, Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
irst@ml.res.ncc.go.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 | 05 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To retrospectively investigate the technical and clinical success, safety profile, time to recurrent biliary obstruction (TRBO), and re-intervention success of EUS-HDS in patients with unresectable MHBO.
Management information
Registered date
| 2026 | Year | 05 | Month | 01 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070254
