UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061423 |
|---|---|
| Receipt number | R000070284 |
| Scientific Title | Long-term outcomes of endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine tumors |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2026/04/30 22:32:16 |
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Basic information
Public title
Long-term outcomes of endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine tumors
Acronym
EUS-RFA for Pancreatic NET Long-term Outcomes Study
Scientific Title
Long-term outcomes of endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine tumors
Scientific Title:Acronym
EUS-RFA for Pancreatic NET Long-term Outcomes Study
Region
| Japan |
Condition
Condition
Pancreatic neuroendocrine tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is a minimally invasive treatment option for small, low-grade pancreatic neuroendocrine neoplasms (PNENs). While a multicenter prospective study is currently evaluating its short-term efficacy and safety, data on long-term outcomes remain limited. This study aims to prospectively assess the long-term outcomes following EUS-RFA as an ancillary study, focusing on local recurrence, distant metastasis, and long-term effects on pancreatic endocrine and exocrine function.
Basic objectives2
Others
Basic objectives -Others
long-term outcomes and long-term effects
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse-free survival (RFS)
*The primary endpoint will be assessed only in patients who achieved curative treatment (complete ablation), as defined in the preceding study.
Key secondary outcomes
Overall survival (OS), progression-free survival (PFS), incidence and worsening of diabetes mellitus, late procedure-related adverse events, and treatment strategies for recurrent or non-curative cases
*Secondary endpoints will be assessed in all patients, including those with non-curative treatment (incomplete ablation), as defined in the preceding study.
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 multicenter prospective study titled (Evaluation of the efficacy and safety of endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine neoplasms).
Patients from whom written informed consent for participation in this study can be obtained based on their own free will.
Key exclusion criteria
none
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | kazuyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama university hospital
Division name
Gastroenterology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama 700-8558, Japan
TEL
086-235-7219
matsumoto.k@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Fujii |
Organization
Okayama university hospital
Division name
Gastroenterology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama 700-8558, Japan
TEL
086-235-7219
Homepage URL
pmug1j9r@okayama-u.ac.jp
Sponsor or person
Institute
Okayama university
Institute
Department
Personal name
Funding Source
Organization
none
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
Clinical Research Review Committee of the Institutional Review Board, Okayama University (Medical Sciences Division)
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama 700-8558, 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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 30 | 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
| 2026 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 04 | Month | 30 | Day |
Last modified on
| 2026 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070284
