UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059659 |
|---|---|
| Receipt number | R000067611 |
| Scientific Title | A multicenter prospective study on the efficacy of endoscopic ultrasound-guided antegrade stenting combined with hepaticogastrostomy (EUS-AS+HGS) for unresectable malignant biliary obstruction |
| Date of disclosure of the study information | 2025/11/06 |
| Last modified on | 2025/11/06 08:44:39 |
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Basic information
Public title
A multicenter prospective study on the efficacy of endoscopic ultrasound-guided antegrade stenting combined with hepaticogastrostomy (EUS-AS+HGS) for unresectable malignant biliary obstruction
Acronym
A multicenter prospective study on the efficacy of endoscopic ultrasound-guided antegrade stenting combined with hepaticogastrostomy (EUS-AS+HGS): comparison with historical EUS-HGS data
Scientific Title
A multicenter prospective study on the efficacy of endoscopic ultrasound-guided antegrade stenting combined with hepaticogastrostomy (EUS-AS+HGS) for unresectable malignant biliary obstruction
Scientific Title:Acronym
A multicenter prospective study on the efficacy of endoscopic ultrasound-guided antegrade stenting combined with hepaticogastrostomy (EUS-AS+HGS)
Region
| Japan |
Condition
Condition
Patients with unresectable malignant biliary obstruction for whom transpapillary treatment is difficult, necessitating EUS-BD, in whom EUS-AS+HGS is attempted.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy of EUS-guided antegrade stenting combined with hepaticogastrostomy (EUS-AS+HGS) as a biliary drainage method in patients with unresectable malignant biliary obstruction in whom transpapillary treatment is not feasible. A multicenter prospective design will be employed, and outcomes will be compared with historical data of EUS-HGS using metal stents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Time to recurrent biliary obstruction (TRBO) and its comparison with historical data
Key secondary outcomes
1. Technical success rate
2. Clinical success rate
3. Adverse event rate
4. Length of hospital stay
5. Overall survival
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with unresectable advanced malignant tumors.
2. Patients with obstructive jaundice due to malignant tumors requiring biliary drainage.
3. Patients in whom ERCP-guided biliary drainage is not feasible or has failed.
4. Patients with obstructive jaundice due to malignant tumors who undergo EUS-AS+HGS as the biliary drainage procedure.
5. Patients in whom intrahepatic bile duct dilatation is confirmed by ultrasonography, CT, or other imaging modalities.
6. Patients aged 20 years or older at the time of consent.
Key exclusion criteria
1. Patients in whom endoscopic approach is not feasible.
2. Patients with a performance status of 4.
3. Patients with severe comorbidities involving other organs.
4. Patients who are unable to provide informed consent.
5. Any other patients deemed inappropriate for inclusion in the study by the principal or sub-investigator.
Target sample size
49
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Itonaga |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300
Homepage URL
itonaga@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Masayuki KItano
Funding Source
Organization
None
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
Institutional Review Board (IRB), Wakayama Medical University
Address
811-1 Kimiidera, Wakayama City
Tel
073-447-2300
wa-rinri@wakayama-med.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
和歌山県立医科大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 06 | 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
39
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 31 | Day |
Other
Other related information
1. The principal investigator or a co-investigator will provide an explanation of the study to patients who may be eligible and obtain written informed consent.
2. After obtaining consent, endoscopic ultrasound-guided biliary drainage (EUS-BD) will be performed for eligible patients. Endoscopic and fluoroscopic images of each case will be recorded as digital images.
3. The following outcomes will be evaluated: time to recurrent biliary obstruction, technical success rate, clinical success rate, procedure time, and adverse events.
4. After the procedure, patients will be followed until the end of the observation period.
Management information
Registered date
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067611
