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NCT Number: NCT05117047

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

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.

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Key information

Conditions

Long-term Effects of Cancer Treatment

Age range

14 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

liver resection

Procedure

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.

Primary outcomes

  1. Overall Survival

    Time frame: 14/02/2015-30/06/2021

    The primary outcomes of this study included long-term oncological outcomes of OS

  2. Disease free Survival

    Time frame: 14/02/2015-30/06/2021

    The primary outcomes of this study included long-term oncological outcomes of DFS

Secondary outcomes

  1. postoperative complications

    Time frame: 14/02/2015-30/06/2021

    Postoperative morbidity and mortality were assessed according to the Clavien-Dindo classification

  2. Textbook Outcome in liver surgery (TOLS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chen Xiaoping

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2021
First posted
Nov 11, 2021
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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