UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061866 |
|---|---|
| Receipt number | R000070788 |
| Scientific Title | A Randomized Controlled Non-Inferiority Trial Comparing the Efficacy and Safety of 19-Gauge versus 22-Gauge Needle Puncture Approaches in Endoscopic Ultrasound-Guided Hepaticogastrostomy/Hepaticojejunostomy (EUS-HGS/HJS) |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/06/11 12:08:28 |
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Basic information
Public title
A Randomized Controlled Non-Inferiority Trial Comparing the Efficacy and Safety of 19-Gauge versus 22-Gauge Needle Puncture Approaches in Endoscopic Ultrasound-Guided Hepaticogastrostomy/Hepaticojejunostomy (EUS-HGS/HJS)
Acronym
A Randomized Controlled Non-Inferiority Trial Comparing the Efficacy and Safety of 19-Gauge versus 22-Gauge Needle Puncture Approaches in Endoscopic Ultrasound-Guided Hepaticogastrostomy/Hepaticojejunostomy (EUS-HGS/HJS)
Scientific Title
A Randomized Controlled Non-Inferiority Trial Comparing the Efficacy and Safety of 19-Gauge versus 22-Gauge Needle Puncture Approaches in Endoscopic Ultrasound-Guided Hepaticogastrostomy/Hepaticojejunostomy (EUS-HGS/HJS)
Scientific Title:Acronym
A Randomized Controlled Non-Inferiority Trial Comparing the Efficacy and Safety of 19-Gauge versus 22-Gauge Needle Puncture Approaches in Endoscopic Ultrasound-Guided Hepaticogastrostomy/Hepaticojejunostomy (EUS-HGS/HJS)
Region
| Japan |
Condition
Condition
Biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the non-inferiority of the 22-gauge needle puncture approach compared with the 19-gauge needle puncture approach in EUS-guided hepaticogastrostomy/hepaticojejunostomy (EUS-HGS/HJS) for patients with biliary obstruction unsuitable for or refractory to transpapillary biliary drainage, using technical success rate as the primary endpoint.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Technical success rate of EUS-HGS/HJS assessed at the completion of the procedure.
Key secondary outcomes
1.Procedure time (time from needle insertion through the echoendoscope to successful stent deployment)
2.Incidence and types of procedure-related adverse events within 30 days after the procedure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
During EUS-guided hepaticogastrostomy/hepaticojejunostomy (EUS-HGS/HJS), biliary puncture and stent placement will be performed using a 19-gauge needle and a 0.025-inch guidewire.
Interventions/Control_2
During EUS-guided hepaticogastrostomy/hepaticojejunostomy (EUS-HGS/HJS), biliary puncture and stent placement will be performed using a 22-gauge needle and a 0.018-inch guidewire.
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 biliary obstruction requiring biliary drainage and intrahepatic bile duct dilatation of 3 mm or greater on imaging studies, who are considered unsuitable for or refractory to transpapillary biliary drainage and are candidates for EUS-HGS/HJS.
2. Age 20 years or older.
3. Written informed consent obtained.
Key exclusion criteria
1. ECOG Performance Status 4.
2. Intrahepatic bile duct dilatation < 3 mm.
3. Inability to discontinue antithrombotic agents.
4. Pregnancy or suspected pregnancy.
5. Cases judged unsuitable for safe puncture.
6. Intervening vessels, varices, or tumors along the puncture route.
7. Massive ascites.
8. Platelet count < 50,000/uL.
9. PT-INR >= 1.5.
10. Any patient considered inappropriate by the investigators.
Target sample size
166
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yasuda |
Organization
University of Toyama Hospital
Division name
Third Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama 930-0194, Japan
TEL
0764347301
yasudaich@gmail.com
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Kitamura |
Organization
University of Toyama Hospital
Division name
Third Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama 930-0194, Japan
TEL
0764347301
Homepage URL
kitamu19@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama Hospital
Institute
Department
Personal name
Ichiro Yasuda
Funding Source
Organization
University of Toyama Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shiga University of Medical Science Hospital
Gifu Municipal Hospital
Matsunami General Hospital
Teikyo University Mizonokuchi Hospital
Gifu University Hospital
Gifu Prefectural General Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Research Ethics Involving Human Subjects, University of Toyama
Address
2630 Sugitani, Toyama, Toyama 930-0194, Japan
Tel
076-415-8857
kenrinri@adm.u-toyama.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
富山大学附属病院（富山県）
滋賀医科大学医学部附属病院（滋賀県）
岐阜市民病院（岐阜県）
松波総合病院（岐阜県）
帝京大学医学部附属溝口病院（神奈川県）
岐阜大学医学部附属病院（岐阜県）
岐阜県総合医療センター（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 30 | 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
| 2026 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2028 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
This is a multicenter prospective randomized controlled non-inferiority trial evaluating the non-inferiority of the 22-gauge needle approach compared with the 19-gauge needle approach in EUS-guided hepaticogastrostomy/hepaticojejunostomy.
Management information
Registered date
| 2026 | Year | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070788
