UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062694 |
|---|---|
| Receipt number | R000071782 |
| Scientific Title | A Phase I Study of a Novel Linkage Technique for Multisegmental Biliary Drainage Through a Single EUS-HGS or EUS-HDS Fistula in Unresectable Malignant Hilar Biliary Obstruction |
| Date of disclosure of the study information | 2026/08/26 |
| Last modified on | 2026/08/26 11:27:41 |
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Basic information
Public title
A Phase I Study of a Novel Linkage Technique for Multisegmental Biliary Drainage Through a Single EUS-HGS or EUS-HDS Fistula in Unresectable Malignant Hilar Biliary Obstruction
Acronym
Linkage technique of EUS-BD for MHBO
Scientific Title
A Phase I Study of a Novel Linkage Technique for Multisegmental Biliary Drainage Through a Single EUS-HGS or EUS-HDS Fistula in Unresectable Malignant Hilar Biliary Obstruction
Scientific Title:Acronym
Linkage technique of EUS-BD for MHBO
Region
| Japan |
Condition
Condition
Unresectable malignant hilar biliary obstruction
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of a novel linkage biliary drainage technique connecting two ipsilateral intrahepatic bile duct branches through a single EUS-HGS or EUS-HDS fistula in patients with unresectable malignant hilar biliary obstruction.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Technical success rate, clinical success rate, procedure time, stent patency duration, and the incidence and details of re-interventions.
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
| Maneuver |
Interventions/Control_1
As biliary drainage for malignant hilar biliary obstruction, EUS-guided biliary drainage of two ipsilateral intrahepatic bile duct branches (e.g., B2 and B3 or B6 and B7) is performed in a single session through a single fistula using EUS-HGS or EUS-HDS.
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
1.Patients with unresectable malignant hilar biliary obstruction classified as Bismuth type III or higher who require biliary drainage of multiple intrahepatic bile duct branches within the same
hepatic lobe.
2.Patients aged 20 years of age or older at the time informed consent is obtained.
3.Patients who have provided written informed consent to participate in the study.
4.Patients whose general condition is considered adequate to safely undergo endoscopic procedures.
5.Patients with adequate major organ function, including bone marrow, cardiac, hepatic, pulmonary, and renal function.
6.Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2.
Key exclusion criteria
1.Patients with marked ascites in whom a safe puncture route cannot be secured.
2.Patients considered to be at high risk of bleeding or with any of the following coagulation abnormalities:
Platelet count <50,000
PT-INR >=1.5
APTT >1.5 times the upper limit of normal
3.Patients with obvious disseminated tumor nodules or other findings on imaging that make safe puncture difficult.
4.Patients who are considered unsuitable for participation in this study by the investigator.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Hara |
Organization
Aichi Cancer Center
Division name
Department of Gastroenterology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
0527626111
khara@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Okuno |
Organization
Aichi Cancer Center
Division name
Department of Gastroenterology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
0527626111
Homepage URL
https://cancer-c.pref.aichi.jp/department/clinical-research/
nokuno@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
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
IRB, Aichi Cancer Center Hospital
Address
1-1, Kanokoden, Chikusa-ku, Nacoya, Aichi, Japan
Tel
0527626111
irb@aichi-cc.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2026-0-148
Org. issuing International ID_1
Aichi Cancer Center
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 | 08 | Month | 26 | 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 | 05 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 03 | 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 | 08 | Month | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071782
