A Long-term Survival Analysis of Different Surgical Method in Early Hepatocellular Carcinoma
- Conditions
- Long-term Effects of Cancer Treatment
- Interventions
- Procedure: liver resection
- Registration Number
- NCT05117047
- Lead Sponsor
- Chen Xiaoping
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 369
- 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
- with any history of malignant tumors; with treatment of ablation, TACE or TKI history before liver resection.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description robot-assisted liver resection 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. laparoscopic liver resection 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. open liver resection 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.
- Primary Outcome Measures
Name Time Method Overall Survival 14/02/2015-30/06/2021 The primary outcomes of this study included long-term oncological outcomes of OS
Disease free Survival 14/02/2015-30/06/2021 The primary outcomes of this study included long-term oncological outcomes of DFS
- Secondary Outcome Measures
Name Time Method postoperative complications 14/02/2015-30/06/2021 Postoperative morbidity and mortality were assessed according to the Clavien-Dindo classification
Textbook Outcome in liver surgery (TOLS) 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.
Trial Locations
- Locations (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China