A Long-term Survival Analysis of Different Surgical Method in Early Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Long-term Effects of Cancer Treatment

Intervention / Treatment
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* Procedure: liver resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| robot-assisted liver resection<br>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. | Procedure: liver resection<br>* 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.<br>|
| laparoscopic liver resection<br>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. | Procedure: liver resection<br>* 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.<br>|
| open liver resection<br>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. | Procedure: liver resection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The primary outcomes of this study included long-term oncological outcomes of OS | 14/02/2015-30/06/2021 | 
| Disease free Survival | 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 | Postoperative morbidity and mortality were assessed according to the Clavien-Dindo classification | 14/02/2015-30/06/2021 | 
| Textbook Outcome in liver surgery (TOLS) | 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 |