UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044973 |
|---|---|
| Receipt number | R000051386 |
| Scientific Title | A single-center prospective study on the safety of endobiliary radiofrequency ablation of hilar malignant biliary stenosis |
| Date of disclosure of the study information | 2021/07/27 |
| Last modified on | 2021/07/27 21:22:07 |
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Basic information
Public title
A single-center prospective study on the safety of endobiliary radiofrequency ablation of hilar malignant biliary stenosis
Acronym
Safety of endobiliary RFA for hilar malignant biliary stenosis
Scientific Title
A single-center prospective study on the safety of endobiliary radiofrequency ablation of hilar malignant biliary stenosis
Scientific Title:Acronym
Safety of endobiliary RFA for hilar malignant biliary stenosis
Region
| Japan |
Condition
Condition
hilar malignant biliary stenosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety of endoscopic radiofrequency ablation of hilar malignant biliary stenosis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
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 | Maneuver |
Interventions/Control_1
endobiliary radiofrequency ablation
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. Unresectable malignant hilar biliary obstruction with pathological proof
2.Bismuth classification 2,3,4
3.ECOG performance status 0-3
4.Given written informed consent
Key exclusion criteria
1.Patients in whom the endoscope cannot reach the duodenal papilla
2.Patients with jaundice or cholangitis that cannot be controlled by biliary drainage
3.Patients with serious complications in other organs: ASA classification of 3 or higher
4.Patients with a life expectancy of less than 3 months
5.Patients with a history of surgical gastrointestinal reconstruction
6.Patients with significant invasion of the hepatic artery by the tumor
7.Patients who are deemed inappropriate by the researcher
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Arata |
| Middle name | |
| Last name | Sakai |
Organization
Kobe University Hospital
Division name
Division of gastroenterology, Department of Internal medicine
Zip code
6500017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
+81-78-382-5774
asakai@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Arata |
| Middle name | |
| Last name | Sakai |
Organization
Kobe University Hospital
Division name
Division of gastroenterology, Department of Internal medicine
Zip code
650-0017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
+81-78-382-5774
Homepage URL
asakai@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate school of Medicine
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
kobe University IRB office
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-382-6669
kainyu@med.kobe-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
| 2021 | Year | 07 | Month | 27 | 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
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2021 | Year | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051386
