UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026177 |
|---|---|
| Receipt number | R000030078 |
| Scientific Title | Endoscopic biliary radiofrequency ablation with multiple metal stents in patients with unresectable malignant hilar biliary stenosis: A multicenter prospective observation study |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2021/08/21 09:29:25 |
* 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
Endoscopic biliary radiofrequency ablation with multiple metal stents in patients with unresectable malignant hilar biliary stenosis: A multicenter prospective observation study
Acronym
Endoscopic biliary radiofrequency ablation with multiple metal stents
Scientific Title
Endoscopic biliary radiofrequency ablation with multiple metal stents in patients with unresectable malignant hilar biliary stenosis: A multicenter prospective observation study
Scientific Title:Acronym
Endoscopic biliary radiofrequency ablation with multiple metal stents
Region
| Japan |
Condition
Condition
patients with unresectable malignant hilar biliary stenosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of biliary radiofrequency ablation with multiple metal stents
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate for the procedures of endoscopic biliary radiofrequency ablation with multiple metal stents
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 |
Interventions/Control_1
Endoscopic biliary radiofrequency ablation with multiple metal stents
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.Patients with unresectable malignant hilar stenosis
2.Patients who are scheduled for initial placement of multiple metal stents
3.The patient over the age of 20.
4.Written informed consent
Key exclusion criteria
1.Performance status 4
2.The patient has a severe comorbidity: American Society of Anesthesiologists classification from 3 to 5
3.The patient is pregnant or suspected pregnancy.
4.The patient cannot undergo duodenoscopic procedures such as a case with surgically altered anatomy or a case with a stenosis of gastrointestinal tract.
5.The patient received implantation of pacemaker.
6.The patient has a tendency to bleed.
7.The patient prohibited the participant of this study by their research investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Hashimoto |
Organization
Kagoshima University
Division name
Digestive and Lifestyle Diseases
Zip code
8908544
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755326
kumdsh@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Hashimoto |
Organization
Kagoshima University
Division name
Digestive and Lifestyle Diseases
Zip code
8908544
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755326
Homepage URL
kumdsh@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Digestive and Lifestyle Diseases, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Digestive and Lifestyle Diseases, Kagoshima University
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
Ethics Committee on Clinical Research, Kagoshima University Hospital
Address
8-35-1 Sakuragaoka, Kagoshima
Tel
0992756692
kufsyomu@kuas.kagoshima-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
| 2017 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2017 | Year | 02 | Month | 16 | Day |
Last modified on
| 2021 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030078
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
