UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049970 |
|---|---|
| Receipt number | R000056915 |
| Scientific Title | Impact of sarcopenia on clinical outcomes for patients with resected hepatocellular carcinoma: A retrospective comparison of eastern and western cohorts |
| Date of disclosure of the study information | 2023/01/16 |
| Last modified on | 2024/01/06 12:16:17 |
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Basic information
Public title
Impact of sarcopenia on clinical outcomes for patients with resected hepatocellular carcinoma: A retrospective comparison of eastern and western cohorts
Acronym
Impact of sarcopenia on clinical outcomes for patients with resected hepatocellular carcinoma: A retrospective comparison of eastern and western cohorts
Scientific Title
Impact of sarcopenia on clinical outcomes for patients with resected hepatocellular carcinoma: A retrospective comparison of eastern and western cohorts
Scientific Title:Acronym
Impact of sarcopenia on clinical outcomes for patients with resected hepatocellular carcinoma: A retrospective comparison of eastern and western cohorts
Region
| Japan | Europe |
Condition
Condition
Patients who underwent liver resection for hepatocellular carcinoma.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Muscle mass, as a reflection thereof, can be objectively measured. However, the role of east-west differences remains unclear. Therefore, we compared the impact of muscle mass on clinical outcomes after liver resection for HCC in a Dutch and Japanese setting and evaluated the predictive performance of different cut-off values for sarcopenia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was overall survival (OS), defined as the time in days between the date of resection and the date of death or last follow-up.
Key secondary outcomes
We investigated short-term outcome measures: recurrence free survival (RFS), length of hospital stay, complications with Clavien-Dindo grade (CD) > 2, and 90-day mortality.
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
All consecutive patients that had HCC and received curative liver resection at Erasmus MC, Netherlands, and Okayama University Hospital, Japan, in the period between January 2000 and January 2020 were included.
Key exclusion criteria
Patients were excluded if: HCC was not confirmed upon histopathological examination or if no preoperative computed tomography (CT) scan was available within three months prior to the resection.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Takagi |
Organization
Okayama University Hospital
Division name
Department of Gastroenterological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
+81-86-223-7151
kotakagi15@gmail.com
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Takagi |
Organization
Okayama University Hospital
Division name
Department of Gastroenterological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
+81-86-223-7151
Homepage URL
kotakagi15@gmail.com
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable.
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
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
+81-86-223-7151
kotakagi15@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
MEC-2018-1544
Org. issuing International ID_1
Medical Ethics Committee of Erasmus MC
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
https://journals.lww.com/international-journal-of-surgery/pages/articleviewer.aspx?year=2023&issue=0
Publication of results
Unpublished
Result
URL related to results and publications
https://journals.lww.com/international-journal-of-surgery/pages/articleviewer.aspx?year=2023&issue=0
Number of participants that the trial has enrolled
700
Results
The predictive performance of sarcopenia for both short-term and long-term outcomes was higher in JP compared to NL (maximum C-index: 0.58 vs. 0.55, respectively). However, differences between cutoff values were small. For the association between sarcopenia and OS, a strong association was found in JP [hazard ratio (HR) 2.00, 95% CI [1.230-3.08], P =0.002], where this was not found in NL (0.76 [0.42-1.36], P =0.351).
Results date posted
| 2024 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this multicenter retrospective cohort study, patients with HCC undergoing liver resection were included.
Participant flow
In this multicenter retrospective cohort study, patients with HCC undergoing liver resection were included.
Adverse events
Demographics differed between NL and JP. Gender, age, and body mass index were associated with SMI. Significant effect modification between NL and JP was found for BMI. The predictive performance of sarcopenia for both short-term and long-term outcomes was higher in JP compared to NL (maximum C-index: 0.58 vs. 0.55, respectively). However, differences between cutoff values were small. For the association between sarcopenia and OS, a strong association was found in JP [hazard ratio (HR) 2.00, 95% CI [1.230-3.08], P =0.002], where this was not found in NL (0.76 [0.42-1.36], P =0.351). The interaction term confirmed that this difference was significant (HR 0.37, 95% CI [0.19-0.73], P =0.005).
Outcome measures
The skeletal muscle mass index (SMI) was determined on computed tomography scans obtained within 3 months before surgery. The primary outcome measure was overall survival (OS). Secondary outcome measures were: 90-day mortality, severe complications, length of stay, and recurrence-free survival. The predictive performance of several sarcopenia cutoff values was studied using the concordance index (C-index) and area under the curve. Interaction terms were used to study the geographic effect modification of muscle mass.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056915
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