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

Long-term Effects of Cancer Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117047
• Other study ID #: C201501
• Status: Completed
• Start date: February 14, 2015
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2021
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2017
• Gender: All
• Age group: 14 Years to 75 Years

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Long-term Effects of Cancer Treatment

Intervention

Procedure:
• liver 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.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chen Xiaoping

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	The primary outcomes of this study included long-term oncological outcomes of OS	14/02/2015-30/06/2021
Primary	Disease free Survival	The primary outcomes of this study included long-term oncological outcomes of DFS	14/02/2015-30/06/2021
Secondary	postoperative complications	Postoperative morbidity and mortality were assessed according to the Clavien-Dindo classification	14/02/2015-30/06/2021
Secondary	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