- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06950827
Textbook Outcomes of Right Hemihepatectomy in Patients With Hepatocellular Carcinoma
April 22, 2025 updated by: Jiwei Huang, West China Hospital
Textbook Outcomes of Right Hemihepatectomy in Patients With Hepatocellular Carcinoma: a Comparative Study of Laparoscopic and Open Surgery
Although traditional open right hemihepatectomy is a mature technique, the incision is usually very large; Intraoperative bleeding may be excessive, and postoperative liver failure is also prone to occur.
In recent years, compared with traditional open surgery, laparoscopic surgery has many advantages, such as smaller surgical incision and faster postoperative recovery.
In recent years, more and more centers have gradually transitioned to performing right hemihepatectomy through laparoscopy as much as possible.
However, due to the difficulty of the surgery, steep learning curve, and postoperative complications, its adoption is limited to high-capacity surgical centers.
Despite significant progress in laparoscopic liver resection technology, its clinical efficacy remains controversial, especially in laparoscopic right hemihepatectomy.
More research is needed to confirm the feasibility and safety of this surgery.
At present, it is unclear whether there is a difference in textbook outcomes (TO) between HCC patients undergoing open and laparoscopic right hemihepatectomy, and the association between TO and patient survival prognosis.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiwei Huang Professor
- Phone Number: +86 18980606725
- Email: huangjiwei@wchscu.cn
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- West China Hospital
-
Contact:
- Jiwei Huang Huang Professor
- Phone Number: +86 18980606725
- Email: huangjiwei@wchscu.cn
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The data was collected from patients who underwent right hemihepatectomy and were diagnosed with HCC pathologically.
The data was collected from the division of Liver Surgery of West China Hospital, SCU from January 2018 to January 2023.
Description
Inclusion Criteria:
- Age ≥ 18 years old;
- The lesion is limited to the right half of the liver and diagnosed as hepatocellular carcinoma based on paraffin pathology and immunohistochemistry results;
- The type of surgery is elective surgery;
- The patient's preoperative liver function was Child Pugh A or B grade, and the preoperative ASA (American Society of Anesthesiologists) rating was I, II, or III.
Exclusion Criteria:
- Pathological confirmed cholangiocarcinoma, mixed cell carcinoma, or extrahepatic metastatic malignant tumors;
- Previous history of upper abdominal surgery;
- Simultaneously undergoing adjacent abdominal organ resection, major vessel and biliary reconstruction surgery, except for the gallbladder;
- Merge adjacent organ invasions except for the gallbladder, with main blood vessels, bile duct cancer emboli, or distant metastases;
- Lost to follow-up or loss of primary clinical data.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hepatocellular carcinoma patients who received laparoscopic right hemihepatectomy
|
Laparoscopic surgery has many advantages, such as small surgical incision and fast postoperative recovery.
In recent years, more and more centers have gradually transitioned to performing right hemihepatectomy through laparoscopy as much as possible.
|
|
Hepatocellular carcinoma patients who received open right hemihepatectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Textbook outcome
Time Frame: From January 2018 to January 2023
|
Textbook outcome (TO) was defined as the absence of intraoperative grade ≥ 2 incidents (defined according to the Oslo classification), postoperative bile leak of grade B or C (according to the severity grading of the International Study Group of Liver Surgery), postoperative liver failure grade B or C (according to the severity grading of the International Study Group of Liver Surgery), major postoperative complications within 90 days (Clavien-Dindo grade III or higher), readmission within 90 days after discharge due to surgery related major complications (Clavien-dindo Grade III or higher), in-hospital or 90-day mortality and the presence of R0 resection margin (i.e.
1mm or more tumor free margin).
|
From January 2018 to January 2023
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: From January 2018 to January 2023
|
Overall survival (OS) was defined as the interval from liver resection to death or the last follow-up.
|
From January 2018 to January 2023
|
|
Disease-free survival
Time Frame: From January 2018 to January 2023
|
Disease-free survival (DFS) was defined as the time from liver resection to disease recurrence or death from any cause.
|
From January 2018 to January 2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 5, 2025
Primary Completion (Estimated)
May 10, 2025
Study Completion (Estimated)
May 15, 2025
Study Registration Dates
First Submitted
April 22, 2025
First Submitted That Met QC Criteria
April 22, 2025
First Posted (Actual)
April 30, 2025
Study Record Updates
Last Update Posted (Actual)
April 30, 2025
Last Update Submitted That Met QC Criteria
April 22, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JHuang20232
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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