UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060980 |
|---|---|
| Receipt number | R000069780 |
| Scientific Title | A novel fine-caliber strategy for EUS-guided hepaticogastrostomy using a 22-gauge needle and 0.018-inch guidewire: a multicenter prospective study |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/19 07:45:55 |
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Basic information
Public title
A novel fine-caliber strategy for EUS-guided hepaticogastrostomy using a 22-gauge needle and 0.018-inch guidewire: a multicenter prospective study
Acronym
A novel fine-caliber strategy for EUS-guided hepaticogastrostomy using a 22-gauge needle and 0.018-inch guidewire: a multicenter prospective study
Scientific Title
A novel fine-caliber strategy for EUS-guided hepaticogastrostomy using a 22-gauge needle and 0.018-inch guidewire: a multicenter prospective study
Scientific Title:Acronym
A novel fine-caliber strategy for EUS-guided hepaticogastrostomy using a 22-gauge needle and 0.018-inch guidewire: a multicenter prospective study
Region
| Japan |
Condition
Condition
Biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Technical feasibility
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome:
Technical success rate
Definition:
Technical success is defined as successful placement of a stent in the target bile duct using a 22-gauge needle and the J-Wire NM (0.018-inch guidewire) during EUS-guided hepaticogastrostomy. No restriction is imposed on the type of stent used.
Key secondary outcomes
a) Adverse events: incidence and types
Adverse events will be evaluated in accordance with the criteria of the American Society for Gastrointestinal Endoscopy. The definitions of anticipated adverse events are as follows:
Bleeding: Presence of overt bleeding such as hematemesis or melena, or a decrease in hemoglobin level of >2g/dL on the day following the procedure.
Perforation: Perforation associated with the endoscopic procedure.
b) Procedure time
Procedure time is defined as the interval from bile duct puncture to completion of stent placement.
c) Use of dilation devices and their types
Dilation is not routinely performed. However, dilation is permitted when insertion of the stent delivery system is not feasible. No restriction is imposed on the type of dilation device used.
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
| Device,equipment |
Interventions/Control_1
22G, 0.018-inch guidewire
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with biliary stricture in whom Endoscopic Retrograde Cholangiopancreatography is difficult or unsuccessful
Age >18 years and <99 years at the time of enrollment
Written informed consent obtained from the patient prior to participation in the study
Key exclusion criteria
Exclusion criteria:
Patients with severe bleeding tendency or pregnancy
Patients who have already undergone alternative biliary drainage procedures
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Pancreatobiliary Advanced Medical Center
Zip code
5698686
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
+81-726831221
oguratakeshi0411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Pancreatobiliary Advanced Medical Center
Zip code
5698686
Address
2-7 Daigakuchou, Takatsukishi
TEL
+81-726831221
Homepage URL
oguratakeshi0411@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University 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
the Human Research Committee of Osaka Medical and Pharmaceutical University
Address
2-7 Daigakuchou, Takatsukishi
Tel
+81-726831221
rinri@ompu.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | 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
| 2025 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 11 | Month | 01 | 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 | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069780
