Long-term Effects of Cancer Treatment
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China