- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05339919
Relationship Between Liver Cancer and Sarcopenia
June 14, 2022 updated by: Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University
The Effect of Sarcopenia on Hepatocellular Carcinoma After Hepatectomy
By tracking the short-term and long-term results of patients after hepatectomy, the difference of short-term results between patients with sarcopenia and patients without sarcopenia was analyzed, and the correlation between sarcopenia and short-term and long-term results of patients after hepatectomy was explored, so as to improve people's awareness of sarcopenia and pay attention to its prevention and treatment.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
All implementation details are based on the newest EWGSOP definition.
The investigators consecutively admitted patients the questionnaire and evaluated the assessment of muscle strength (grip strength test and chair stand test), muscle quantity (L3 plane total skeletal muscle area) and physical performance (gait test) following the F-A-C-S approach, to confirm patients with sarcopenia accurately.
And by tracking the short-term and long-term outcomes of patients after hepatectomy, the differences were analyzed and the relationship between sarcopenia and liver cancer was explored.
Study Type
Observational
Enrollment (Anticipated)
1200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Wenzhou, Zhejiang, China, 325000
- Gang Chen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with preoperative clinical diagnosis of liver cancer admitted to the hepatobiliary surgery department and received standard tests and questionnaires.
Description
Inclusion Criteria:
- Patients with preoperative clinical diagnosis of liver cancer
- No cancer other than liver cancer has been diagnosed
- Age ≥18 years
Exclusion Criteria:
- Patients who could not complete the standard tests and questionnaires
- Patients who did not accept liver resection after evaluation of treatment plan
- Patients who had other concomitant preoperative causes of muscle weakness (injury, fracture, stroke, etc.)
- Patients who missing CT data or CT scan did not reach the level of the third lumbar vertebra (L3)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short-term postoperative results
Time Frame: 3 months
|
Postoperative complications;90 days readmission rate
|
3 months
|
|
Long-term results after operation
Time Frame: 10 years
|
Overall survival; Disease free survival
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative hospitalization time
Time Frame: 2 months
|
Time window from the day of operation to the day of discharge.
|
2 months
|
|
Hospitalization expenses
Time Frame: 2 months
|
All hospitalization expenses, including drug expenses, operation expenses, anesthesia expenses, nursing expenses and other expenses.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gang Chen, M.D., First Affiliated Hospital of Wenzhou Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2020
Primary Completion (Actual)
August 11, 2021
Study Completion (Anticipated)
August 28, 2025
Study Registration Dates
First Submitted
April 9, 2022
First Submitted That Met QC Criteria
April 15, 2022
First Posted (Actual)
April 21, 2022
Study Record Updates
Last Update Posted (Actual)
June 15, 2022
Last Update Submitted That Met QC Criteria
June 14, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sarcopenia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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