The influence of body composition on liver cancer patients undergoing surgery
| ISRCTN | ISRCTN12021668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12021668 |
- Submission date
- 30/04/2024
- Registration date
- 01/05/2024
- Last edited
- 09/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Stage I/II hepatocellular carcinoma (HCC) is early-stage liver cancer that is localized to the liver and has not spread to other parts of the body. The effect of body composition on stage I/II HCC after surgery is unknown. This study aimed to investigate the impact of low skeletal muscle bulk and disturbed body fat mass on cancer recurrence in stage I/II HCC patients undergoing liver surgery.
Who can participate?
1. From 2012 to 2021, all stage I and II HCC patients aged between 18 and 90 years old who received curative liver surgery by the same surgical team at Linkou Chang Gung Memorial Hospital
2. Healthy adults aged less than 55 years who had abdominal CT scans
What does the study involve?
Body composition including skeletal muscle mass and body fat volume was measured before surgery with computed tomography (CT scans) in patients with HCC. HCC recurrence outcome was recorded and analyzed. The body composition of healthy adults was also measured with CT scans.
What are the possible benefits and risks of participating?
There are no side effects from participating in the study.
Where is the study run from?
Linkou Chang Gung Memorial Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2021 to July 2023
Who is funding the study?
Linkou Chang Gung Memorial Hospital (UK)
Who is the main contact?
Chao-Wei Lee, alanchaoweilee@hotmail.com
Contact information
Public, Scientific, Principal Investigator
No. 5, Fuxing Street
Guishan District
Taoyuan City
33305
Taiwan
| Phone | +886 (0)975366192 |
|---|---|
| yjding@cgmh.org.tw |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Do low skeletal muscle bulk and disturbed body fat mass impact tumor recurrence in stage I/II hepatocellular carcinoma undergoing surgery? |
| Study objectives | Body composition may influence stage I and II hepatocellular carcinoma (HCC) undergoing curative surgery. |
| Ethics approval(s) |
Approved 20/01/2021, Institutional review board of Chang Gung Memorial Hospital (No. 199, Dunhua North Road, Taipei, 105, Taiwan; +886 (03)3196200#3709; yjding@cgmh.org.tw), ref: 201901879B0 |
| Health condition(s) or problem(s) studied | Hepatocellular carcinoma |
| Intervention | For preoperative tumor staging, all patients recruited will undergo computed tomography (CT) scans no more than 1 month before liver resection. Parameters of body composition will be acquired from non-contrast CT scans with a 5 mm slice thickness. Indices of body composition will be obtained and correlated with tumor recurrence. |
| Intervention type | Other |
| Primary outcome measure | Disease-free survival is calculated from the date of surgery to the date of the first documented clinical disease recurrence and is estimated by Kaplan-Meier survival analysis |
| Secondary outcome measures | 1. Early tumor recurrence, defined as recurrence of the tumor within 2 years of surgery 2. Overall tumor recurrence, defined as the occurrence of the tumor after surgery, measured in years |
| Overall study start date | 01/02/2021 |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 600 |
| Total final enrolment | 541 |
| Key inclusion criteria | 1. Stage I and II HCC patients who received curative liver resection at Linkou Chang Gung Memorial Hospital (CGMH) 2. Patients without cancer who received abdominal CT at Linkou Chang Gung Memorial Hospital (CGMH) |
| Key exclusion criteria | 1. Patients who lacked critical clinical data or image 2. Received concomitant extra-hepatic surgery except for cholecystectomy 3. Underwent intra-operative vascular/biliary reconstruction 4. History of major operations or trauma within 3 months of liver surgery |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 11/01/2021 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Taoyuan
33305
Taiwan
Sponsor information
Hospital/treatment centre
No. 5, Fuxing Street
Guishan District
Taoyuan City
33305
Taiwan
| Phone | +886 (0)3281200-3366 |
|---|---|
| alanlee@cgmh.org.tw | |
| Website | http://www1.cgmh.org.tw/branch/lnk/e/index.aspx |
"ROR" |
https://ror.org/02dnn6q67 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Linkou Chang Gung Memorial Hospital
- Location
- Taiwan
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated or analyzed during the current study may be available upon request from Chao-Wei Lee (alanchaoweilee@hotmail.com), with the permission of the institution. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2024 | 09/06/2025 | Yes | No |
Editorial Notes
09/06/2025: Publication reference added.
30/04/2024: Study's existence confirmed by the institutional review board of Chang Gung Memorial Hospital.
