UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058119 |
|---|---|
| Receipt number | R000065749 |
| Scientific Title | Long-term treatment outcomes after endoscopic ultrasound-guided radiofrequency ablation for liver and pancreatic tumors |
| Date of disclosure of the study information | 2025/06/09 |
| Last modified on | 2025/06/08 00:28:33 |
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Basic information
Public title
Long-term treatment outcomes after endoscopic ultrasound-guided radiofrequency ablation for liver and pancreatic tumors
Acronym
Long-term treatment outcomes after endoscopic ultrasound-guided radiofrequency ablation for liver and pancreatic tumors
Scientific Title
Long-term treatment outcomes after endoscopic ultrasound-guided radiofrequency ablation for liver and pancreatic tumors
Scientific Title:Acronym
Long-term treatment outcomes after endoscopic ultrasound-guided radiofrequency ablation for liver and pancreatic tumors
Region
| Japan |
Condition
Condition
Pancreatic neuroendocrine neoplasm
Solid pseudopapillary neoplasm
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the long-term outcomes after treatment as a supplementary study to the pilot study on the safety and efficacy of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for pancreatic neuroendocrine tumors, as well as the study on the efficacy and safety of EUS-RFA for hepatic and pancreatic tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse-free survival
Key secondary outcomes
Overall survival
Progression-free survival
Incidence and worsening rate of diabetes mellitus
Late procedure-related complications
Treatment strategies for recurrent or non-curative cases
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
Patients who participated in the study titled "a pilot study on the safety and efficacy of endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine tumors" and the study titled "a study on the efficacy and safety of endoscopic ultrasound-guided radiofrequency ablation for hepatic and pancreatic tumors," and who meet the following criteria:
1. Individuals aged 18 years or older at the time of obtaining consent.
2. Individuals who, after receiving sufficient explanation regarding participation in this study, fully understood the content and voluntarily provided written informed consent
Key exclusion criteria
None
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University Hospital
Division name
Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
matsumotokazuyuki0227@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University Hospital
Division name
Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
Homepage URL
matsumotokazuyuki0227@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Kazuyuki Matsumoto
Funding Source
Organization
Okayama University Hospital Gastroenterology and Hepatology
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
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
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
岡山大学病院(岡山県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe the patient's basic information, blood tests, imaging diagnostics, pathological examinations, and adverse events.
Management information
Registered date
| 2025 | Year | 06 | Month | 08 | Day |
Last modified on
| 2025 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065749
