UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057870 |
|---|---|
| Receipt number | R000066149 |
| Scientific Title | A Multicenter Retrospective Observational Study on Short- and Long-Term Outcomes of Laparoscopic Surgery for Elderly Patients with Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2025/05/14 |
| Last modified on | 2025/05/14 22:29:55 |
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Basic information
Public title
A Multicenter Retrospective Observational Study on Short- and Long-Term Outcomes of Laparoscopic Surgery for Elderly Patients with Hepatocellular Carcinoma
Acronym
A Multicenter Retrospective Study of Laparoscopic Surgery for HCC in the Elderly
Scientific Title
A Multicenter Retrospective Observational Study on Short- and Long-Term Outcomes of Laparoscopic Surgery for Elderly Patients with Hepatocellular Carcinoma
Scientific Title:Acronym
A Multicenter Retrospective Observational Study on Short- and Long-Term Outcomes of Laparoscopic Surgery for Elderly Patients with Hepatocellular Carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular Carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This multicenter study aims to evaluate the short- and long-term outcomes of laparoscopic and open surgery in patients aged 80 years or older with newly diagnosed hepatocellular carcinoma. Regarding prognosis, the study will investigate not only cancer recurrence and treatment outcomes for recurrent hepatocellular carcinoma, but also details of other causes of death, which are more common in elderly patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event of death due to non-liver cancer causes
Key secondary outcomes
Surgical information, Postoperative information, Prognosis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)No restriction on sex
2)Solitary tumor with a maximum diameter within 5 cm
3)No macroscopic vascular invasion of hepatocellular carcinoma
4)Type of hepatic resection (non-anatomical or anatomical) is not restricted
5)Histologically confirmed hepatocellular carcinoma (including combined types)
6)Both open surgery (including thoracoabdominal approaches) and laparoscopic surgery (including laparoscopic-assisted or hand-assisted laparoscopic surgery [HALS]) that meet the above criteria are included
Key exclusion criteria
1)Patients with synchronous (double) cancers
2)Patients who received preoperative locoregional therapy (such as TACE, RFA, or radiotherapy) or preoperative chemotherapy for the target lesion
3)Cases requiring combined vascular resection and reconstruction, or removal of tumor thrombus from within blood vesse
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222264
hnagano@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Tokumitsu |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
7558505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222264
Homepage URL
yt790604@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
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
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-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 | 05 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study investigates the short- and long-term outcomes of laparoscopic and open surgery in elderly patients with newly diagnosed hepatocellular carcinoma. It also examines the presence or absence of recurrence, the treatment details for recurrent hepatocellular carcinoma, survival status, and, in cases of death, the cause of death. These findings will be compared with those of younger patients
Management information
Registered date
| 2025 | Year | 05 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066149
