UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057868 |
|---|---|
| Receipt number | R000066148 |
| Scientific Title | Postoperative Liver Function Assessment in Borderline Resectable Hepatocellular Carcinoma Following Preoperative Drug Therapy |
| Date of disclosure of the study information | 2025/05/14 |
| Last modified on | 2025/05/14 21:10:07 |
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Basic information
Public title
Postoperative Liver Function Assessment in Borderline Resectable Hepatocellular Carcinoma Following Preoperative Drug Therapy
Acronym
Postoperative Liver Function Assessment in BR-HCC Following Preoperative Drug Therapy
Scientific Title
Postoperative Liver Function Assessment in Borderline Resectable Hepatocellular Carcinoma Following Preoperative Drug Therapy
Scientific Title:Acronym
Postoperative Liver Function Assessment in BR-HCC Following Preoperative Drug Therapy
Region
| Japan |
Condition
Condition
Hepatocellular Carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively evaluate postoperative changes in liver function in patients with newly defined borderline resectable (BR) hepatocellular carcinoma and to clarify the safety of this treatment strategy. Patients with resectable hepatocellular carcinoma will be used as a control group, and postoperative liver function will be compared between the BR and resectable HCC groups.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes from baseline in liver function (ALBI score, Child-Pugh score, and ICGR15 value)
Key secondary outcomes
Operative time, blood loss, postoperative complications (Clavien-Dindo classification), overall survival, and recurrence-free survival.
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
1)Patients with a confirmed diagnosis of hepatocellular carcinoma who are scheduled to undergo initial liver resection
2)Patients evaluated as "borderline resectable" or "resectable" based on preoperative assessments, including tumor size, number, and presence or absence of vascular invasion
3)Patients aged 18 years or older at the time of consent
4)No restriction on sex
5)Patients who have received a full explanation of the study and have provided written informed consent of their own free will
Key exclusion criteria
1)Patients with synchronous (double) cancers
2)Patients with a contrast agent allergy
3)Patients with other severe comorbidities (e.g., unstable angina, poorly controlled diabetes)
4)Patients deemed inappropriate for participation in this study by the principal investigator
Target sample size
75
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
| 2025 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, patients with borderline resectable (BR) hepatocellular carcinoma who are scheduled to undergo liver resection will be enrolled. Preoperative and postoperative liver function data obtained from routine clinical practice will be collected, and postoperative changes in liver function will be prospectively observed. As a control group, patients with resectable (R) hepatocellular carcinoma will be included, and changes in postoperative liver function will be compared between the BR and R HCC groups.
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=R000066148
