UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039563 |
|---|---|
| Receipt number | R000045117 |
| Scientific Title | Prospective evaluation of radiofrequency ablation combined with a novel uncovered metal stent placement for distal malignant biliary obstruction |
| Date of disclosure of the study information | 2020/02/21 |
| Last modified on | 2020/02/21 20:21:10 |
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Basic information
Public title
Prospective evaluation of radiofrequency ablation combined with a novel uncovered metal stent placement for distal malignant biliary obstruction
Acronym
Prospective evaluation of radiofrequency ablation combined with a novel uncovered metal stent placement for distal malignant biliary obstruction
Scientific Title
Prospective evaluation of radiofrequency ablation combined with a novel uncovered metal stent placement for distal malignant biliary obstruction
Scientific Title:Acronym
Prospective evaluation of radiofrequency ablation combined with a novel uncovered metal stent placement for distal malignant biliary obstruction
Region
| Japan |
Condition
Condition
unresectable distal malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and efficacy of RFA combined with a novel uncovered metal stent placement for distal malignant biliary obstruction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to recurrent biliary obstruction
Key secondary outcomes
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
Patient with unresectable distal malignant biliary obstruction which require biliary drainage
Key exclusion criteria
1) Patients having difficulty in transpapillary approach
2) Patients with surgically altered anatomy
3) Re-intervention
4) Patients with short length stricture
5) Patients with contraindication of RFA
6) Patients with performance status 4
7) Patients with severe comorbiditeis in any other organs
8) Pregnant women or those suspected of pregnancy
9) Patients without informed consent
10) Inappropriate patients for entry on this study in the judgement of their research investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tadahisa |
| Middle name | |
| Last name | Inoue |
Organization
Aichi Medical University
Division name
Department of Gastroenterology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561623311
tinoue-tag@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tadahisa |
| Middle name | |
| Last name | Inoue |
Organization
Aichi Medical University
Division name
Department of Gastroenterology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561623311
Homepage URL
tinoue-tag@umin.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical 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
Aichi Medical University
Address
1-1 Yazakokarimata Nagakute Aichi
Tel
0561623311
kanrika@aichi-med-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
| 2020 | Year | 02 | Month | 21 | 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
| 2019 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the effeicacy and safety of RFA combined with a novel uncovered metal stent placement for distal malignant biliary obstructions
Management information
Registered date
| 2020 | Year | 02 | Month | 21 | Day |
Last modified on
| 2020 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045117
