UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057192 |
|---|---|
| Receipt number | R000065093 |
| Scientific Title | Efficacy and safety of endoscopic intraductal radiofrequency ablation for obstructed biliary metal stents |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/03 17:03:35 |
* 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
Efficacy and safety of endoscopic intraductal radiofrequency ablation for obstructed biliary metal stents
Acronym
Efficacy of endoscopic intraductal radiofrequency ablation for obstructed biliary metal stents
Scientific Title
Efficacy and safety of endoscopic intraductal radiofrequency ablation for obstructed biliary metal stents
Scientific Title:Acronym
Efficacy of endoscopic intraductal radiofrequency ablation for obstructed biliary metal stents
Region
| Japan |
Condition
Condition
Malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of intraductal radiofrequency ablation in re-intervention of uncovered self-expandable metallic stent occlusion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Non-RBO rate 90 days after endoscopic intraductal radiofrequency ablation
Key secondary outcomes
1. Technical success rate
2. Adverse events
3. Factors associated with failure of endoscopic intraductal radiofrequency ablation
4. Risk factors for RBO
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who will be examined between the date of approval by the head of the research institution and July 31, 2028
2. Patients with histologically proven malignant biliary obstruction
3. Patients who underwent biliary drainage due to uncovered self-expandable metallic stent obstruction
4. Possible to get written informed consent from patients
5. Patients aged 18 years or older at the time of obtaining consent
Key exclusion criteria
1. Patients with acute cholangitis at the time of obtaining consent
2. Postoperative intestinal reconstruction cases (Billroth II, Roux-en-Y, etc.)
3. Patients judged inappropriate by chief medical examiner
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University Hospital
Division name
Department of Endoscopy
Zip code
700-8558
Address
2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
matsumoto.k@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Miyamoto |
Organization
Okayama University Hospital
Division name
Department of Geriatric medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
Homepage URL
ttpcx442@yahoo.co.jp
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama university 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
Okayama University Ethics Review Committee
Address
2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
Tel
086-235-6938
mae6605@adm.okayama-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 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primaly endopoint
Non-RBO rate 90 days after endoscopic intraductal radiofrequency ablation
Secondary endopoints
1. Technical success rate
2. Adverse events
3. Factors associated with failure of endoscopic intraductal radiofrequency ablation
4. Risk factors for RBO
Management information
Registered date
| 2025 | Year | 03 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065093
