UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044094 |
|---|---|
| Receipt number | R000050117 |
| Scientific Title | Long-term outcome of EUS-guided ethanol injection therapy for patients with pancreatic neuroendocrine neoplasm |
| Date of disclosure of the study information | 2021/06/10 |
| Last modified on | 2021/06/18 11:17:08 |
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Basic information
Public title
Long-term outcome of EUS-guided ethanol injection therapy for patients with pancreatic neuroendocrine neoplasm
Acronym
Long-term outcome of ethanol injection therapy for patients with pancreatic neuroendocrine neoplasm
Scientific Title
Long-term outcome of EUS-guided ethanol injection therapy for patients with pancreatic neuroendocrine neoplasm
Scientific Title:Acronym
Long-term outcome of ethanol injection therapy for patients with pancreatic neuroendocrine neoplasm
Region
| Japan |
Condition
Condition
Pancreatic neuroendocrine neoplasm
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term outcomes after EUS-guided ethanol injection therapy for patients with pancreatic neuroendocrine neoplasms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
RFS
Key secondary outcomes
OS
PFS
Incidence and/or exacerbation of DM
Procedure related late adverse events
Treatment for patients with relapse or exacerbation of tumor
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
| 76 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who participated and treated in "EUS-guided ethanol injection therapy for pancreatic neuroendocrine tumors: multicenter prospective intervention study" .
2. Patients who can obtain written informed consent to participate in the research.
Key exclusion criteria
None
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hironari |
| Middle name | |
| Last name | Kato |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
700-8558
Address
2-5-1, shikata-cho, okayama city, okayama
TEL
086-235-7219
katou-h@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 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, okayama city, okayama
TEL
086-235-7219
Homepage URL
matsumoto.k@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Wakayama Medical University Hospital, Hokkaido University Hospital, Aichi Cancer Center Hospital, Kinki University Hospital, Tokyo Medical University Hospital.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital, Ethics Committee
Address
2-5-1, sikata-cho, 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
| 2021 | Year | 06 | Month | 10 | 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
| 2021 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study of 5 years follow up after EUS-guided ethanol injection therapy for PNENs.
Management information
Registered date
| 2021 | Year | 05 | Month | 02 | Day |
Last modified on
| 2021 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050117
