UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056488 |
|---|---|
| Receipt number | R000064550 |
| Scientific Title | Shchedule Stent Exchange Using Plastic Stents after EUS-HES for Malignant Biliary Strictures |
| Date of disclosure of the study information | 2024/12/18 |
| Last modified on | 2024/12/18 11:42:29 |
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Basic information
Public title
Shchedule Stent Exchange Using Plastic Stents after Endoscopic Ultrasound-guided Hepatic Enterostomy (EUS-HES) for Malignant Biliary Strictures
Acronym
Shchedule Stent Exchange Using Plastic Stents afterEUS-HES
Scientific Title
Shchedule Stent Exchange Using Plastic Stents after EUS-HES for Malignant Biliary Strictures
Scientific Title:Acronym
Shchedule Stent Exchange Using Plastic Stents after EUS-HES for Malignant Biliary Strictures
Region
| Japan |
Condition
Condition
Malignant biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical usefulness and safety of routine stent exchange using plastic stents after endoscopic ultrasound-guided hepatic biliary anastomosis (EUS-HES) for malignant biliary strictures
Basic objectives2
Others
Basic objectives -Others
rocedural success rate of stent exchange, rate of stent dislocation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of liver abscess or sepsis during the observation period
Key secondary outcomes
Procedural success rate of stent exchange, rate of stent dislocation
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
EUS-guided hepaticoenterostomy and Stent exchange
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.Cases requiring biliary drainage due to biliary stricture caused by unresectable malignant tumors
2.Cases scheduled for EUS-HES using a metal stent
3.Cases where the patient is 20 years of age or older at the time of obtaining consent
4.Cases where written informed consent has been obtained directly from the patient
Key exclusion criteria
1.Cases in which biliary drainage has already been performed using a transpapillary or percutaneous approach
2.Cases deemed unsuitable for inclusion in this study by the attending physician
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Hara |
Organization
Aichi Cancer Center Hospital
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 Hospital
Division name
Department of Gastroenterology
Zip code
464-8681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
0527626111
Homepage URL
nokuno@aichi-cc.jp
Sponsor or person
Institute
Department of Gastroenterlogy, Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterlogy, Aichi Cancer Center 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
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
2023-0-341
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
| 2024 | Year | 12 | Month | 18 | 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
| 2023 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064550
