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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05117047
Enrollment
369
Registered
2021-11-11
Start date
2015-02-14
Completion date
2021-06-30
Last updated
2021-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term Effects of Cancer Treatment

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

PROCEDUREliver resection

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

Chen Xiaoping
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 75 Years

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

MeasureTime frameDescription
Overall Survival14/02/2015-30/06/2021The primary outcomes of this study included long-term oncological outcomes of OS
Disease free Survival14/02/2015-30/06/2021The primary outcomes of this study included long-term oncological outcomes of DFS

Secondary

MeasureTime frameDescription
postoperative complications14/02/2015-30/06/2021Postoperative morbidity and mortality were assessed according to the Clavien-Dindo classification
Textbook Outcome in liver surgery (TOLS)14/02/2015-30/06/2021Textbook 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026