UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055367 |
|---|---|
| Receipt number | R000063276 |
| Scientific Title | retrospective study on the incidence of long-term postoperative complications in hepatoblastoma surgery |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/08/29 20:00:39 |
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Basic information
Public title
retrospective study on the incidence of long-term postoperative complications in hepatoblastoma surgery
Acronym
retrospective study on the incidence of long-term postoperative complications in hepatoblastoma surgery
Scientific Title
retrospective study on the incidence of long-term postoperative complications in hepatoblastoma surgery
Scientific Title:Acronym
retrospective study on the incidence of long-term postoperative complications in hepatoblastoma surgery
Region
| Japan |
Condition
Condition
Hepatoblastoma
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Hepatoblastoma accounts for approximately 1% of all pediatric solid tumors and is a malignant liver tumor that primarily affects children under the age of five. Complete tumor resection following chemotherapy is crucial as a surgical treatment for hepatoblastoma.
Recently, long-term complications in hepatoblastoma patients have been reported, with chemotherapy-related complications being particularly common. These include ototoxicity, secondary malignancies, and cardiomyopathy, which are frequently reported as long-term complications. However, there are few reports on long-term complications related to surgery.
This study aims to examine the impact of surgical interventions on the long-term complications in hepatoblastoma patients, based on past cases.
Basic objectives2
Others
Basic objectives -Others
Analysis of short and long-term complications after surgery for Hepatoblastoma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of short and long-term complications after surgery for Hepatoblastoma
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
| 1 | days-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hepatoblastoma patients who underwent surgery at the research facility. No new participants will be recruited as the study focuses on patients who were previously treated at our hospital.
Key exclusion criteria
(1) When the information from the research subjects cannot be properly obtained.
(2) Patients who wish to be excluded from the study even after being registered as research subjects.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naonori |
| Middle name | |
| Last name | Kawakubo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Pediatric Surgery
Zip code
8128582
Address
3-1-1, Maidashi, Higashiku, Fukuoka
TEL
0926425573
kawakubo.naonori.061@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Naonori |
| Middle name | |
| Last name | Kawakubo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Pediatric Surgery
Zip code
8128582
Address
3-1-1, Maidashi, Higashiku, Fukuoka
TEL
0926425573
Homepage URL
kawakubo.naonori.061@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
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
Kyushu University
Address
3-1-1, Maidashi, Higashiku, Fukuoka
Tel
092-642-5573
ped-surg@med.kyushu-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
| 2024 | Year | 09 | 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
| 2024 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis items:
Postoperative long-term complication rate in hepatoblastoma patients who underwent surgery.
Clinical findings (age, gender, surgical method), prognosis.
Management information
Registered date
| 2024 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063276
