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

Completed

• Conditions: Long-term Effects of Cancer Treatment

• 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.

Study Timeline

• Study Start: 2015-02-14
• Primary Completion: 2017-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-11
• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-10
• Last Update Submitted: 2021-11-10
• Study First Posted: 2021-11-11
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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