A Long-term Survival Analysis of Different Surgical Method in Early Hepatocellular Carcinoma
November 10, 2021 updated by: Chen Xiaoping
Long-term Survival Analysis of Robotic, Laparoscopic and Open Liver Resection for Hepatocellular Carcinoma in BCLC Stage 0-A: A Prospective Cohort Study With Matched Comparison
The investigators established three prospective cohorts of patients with BCLC stage 0-A HCC, based on different surgical approaches (open, laparoscopic and robotic).
After 5 years of follow-up, the investigators used propensity score matching (PSM) to reduce selection bias and then compared the long-term oncological outcomes of the three different surgical approaches, which might provide high-level evidence in non-randomized observational studies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this study, three prospective cohorts of patients with BCLC stage 0-A HCC, underwent complete liver resection using different surgical approaches (OLR, LLR, and RALR), were established.
After adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (PSM) analysis.
Study Type
Observational
Enrollment (Actual)
369
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
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
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
14 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
1669 cases underwent liver resection from July 1st 2015 to June 30th 2017 in Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, including 186 RALR, 527 LLR, and 956 OLR.
Among these patients, there were 102, 333, and 669 HCC patients, respectively.
Ten patients were excluded due to missing data or follow-up.
Finally, 369 HCC patients in the early stages were included in the analysis.
After PSM, 168 patients were matched and there were 56 patients in each group
Description
Inclusion Criteria:
- All HCC patients in BCLC stage 0-A underwent liver resection in hepatic surgery center, Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology. The inclusion criteria were as follows: 14- 75 years old
Exclusion Criteria:
- with any history of malignant tumors; with treatment of ablation, TACE or TKI history before liver resection.
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 |
|---|---|
|
robot-assisted liver resection
In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received.
These were consecutive patients who met the inclusion criteria of the study.
71 HCC patients were included in robotic liver resection cohort.
|
After adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (PSM) analysis.
|
|
laparoscopic liver resection
In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received.
These were consecutive patients who met the inclusion criteria of the study.
141 HCC patients were included in laparoscopic liver resection cohort.
|
After adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (PSM) analysis.
|
|
open liver resection
In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received.
These were consecutive patients who met the inclusion criteria of the study.
157 HCC patients were included in open liver resection cohort.
|
After adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (PSM) analysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival
Time Frame: 14/02/2015-30/06/2021
|
The primary outcomes of this study included long-term oncological outcomes of OS
|
14/02/2015-30/06/2021
|
|
Disease free Survival
Time Frame: 14/02/2015-30/06/2021
|
The primary outcomes of this study included long-term oncological outcomes of DFS
|
14/02/2015-30/06/2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative complications
Time Frame: 14/02/2015-30/06/2021
|
Postoperative morbidity and mortality were assessed according to the Clavien-Dindo classification
|
14/02/2015-30/06/2021
|
|
Textbook Outcome in liver surgery (TOLS)
Time Frame: 14/02/2015-30/06/2021
|
Textbook Outcome in liver surgery (TOLS), was defined as the absence of intraoperative incidents of grade 2 or higher, postoperative bile leak grade B or C, severe postoperative complications, readmission within 30 days after discharge, in-hospital mortality, and the presence of R0 resection margin.
|
14/02/2015-30/06/2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Xiaoping Chen, Dr, Tongji Hospital
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)
February 14, 2015
Primary Completion (Actual)
June 30, 2017
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
November 3, 2021
First Submitted That Met QC Criteria
November 10, 2021
First Posted (Actual)
November 11, 2021
Study Record Updates
Last Update Posted (Actual)
November 11, 2021
Last Update Submitted That Met QC Criteria
November 10, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C201501
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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