UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056955 |
|---|---|
| Receipt number | R000065086 |
| Scientific Title | Factors associated with early stent dysfunction following plastic stent placement in endoscopic ultrasound-guided hepaticogastrostomy: HGS-PS STUDY |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/02/06 15:11:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Factors associated with early stent dysfunction following plastic stent placement in endoscopic ultrasound-guided hepaticogastrostomy: HGS-PS STUDY
Acronym
Factors associated with early stent dysfunction following plastic stent placement in endoscopic ultrasound-guided hepaticogastrostomy: HGS-PS STUDY
Scientific Title
Factors associated with early stent dysfunction following plastic stent placement in endoscopic ultrasound-guided hepaticogastrostomy: HGS-PS STUDY
Scientific Title:Acronym
Factors associated with early stent dysfunction following plastic stent placement in endoscopic ultrasound-guided hepaticogastrostomy: HGS-PS STUDY
Region
| Japan |
Condition
Condition
Biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the factors associated with early stent dysfunction following plastic stent placement in endoscopic ultrasound-guided hepaticogastrostomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors associated with early stent dysfunction following plastic stent placement in EUS-HGS
Key secondary outcomes
1.Technical success
2.Clinical success
3.Adverse events
4.Overall survival
5.Detailed procedure for stent exchange and re-intervention
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. Over 20 years old
2. Patients with biliary obstruction
3. Patients with performance status 2 or less
4. Patients who underwent plastic stent placement in EUS-HGS
Key exclusion criteria
1. Patients considered ineligible for this study
2. Patients whose implanted plastic stent is an endoscopic nasobiliary drainage tube (ENBD)
3. Patients who underwent antegrade stent placement
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Fujimori |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka 812-8582
TEL
+81-92-642-5285
fujimori.nao.239@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihisa |
| Middle name | |
| Last name | Ohno |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka 812-8582
TEL
+81-92-642-5285
Homepage URL
showa2644aki1aki2@yahoo.co.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kyushu university center for clinical and translational research
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka City, Fukuoka 812-8582
Tel
+81-92-642-6254
ijkseimei@jimu.kyushu-u.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
| 2025 | Year | 03 | 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
| 2024 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter retrospective observational study
Management information
Registered date
| 2025 | Year | 02 | Month | 06 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065086
