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

NCT ID: NCT05117047

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-14

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Long-term Effects of Cancer Treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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robot-assisted liver resection

In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 71 HCC patients were included in robotic liver resection cohort.

liver resection

Intervention Type 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.

laparoscopic liver resection

In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 141 HCC patients were included in laparoscopic liver resection cohort.

liver resection

Intervention Type 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.

open liver resection

In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 157 HCC patients were included in open liver resection cohort.

liver resection

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

* with any history of malignant tumors; with treatment of ablation, TACE or TKI history before liver resection.
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chen Xiaoping

OTHER

Sponsor Role lead

Responsible Party

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Chen Xiaoping

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiaoping Chen, Dr

Role: STUDY_CHAIR

Tongji Hospital

Locations

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

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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C201501

Identifier Type: -

Identifier Source: org_study_id