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

NCT05117047 | Completed

• 1 other identifier: C201501
• Study Type: observational
• Target: 369
• Locations: 1 country
• Sites: 1

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.

Conditions

Long-term Effects of Cancer Treatment

Outcome Measures

Primary Outcomes (2)

• Overall Survival

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

  14/02/2015-30/06/2021

• Disease free Survival

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

  14/02/2015-30/06/2021

Secondary Outcomes (2)

• postoperative complications

  14/02/2015-30/06/2021

• Textbook Outcome in liver surgery (TOLS)

  14/02/2015-30/06/2021

Study Arms (3)

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.

Procedure: liver resection

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.

Procedure: liver resection

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.

Procedure: liver resection

Interventions

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.

laparoscopic liver resection; open liver resection; robot-assisted liver resection

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1669 cases underwent liver resection from July 1st 2015 to June 30th 2017 in Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, including 186 RALR, 527 LLR, and 956 OLR. Among these patients, there were 102, 333, and 669 HCC patients, respectively. Ten patients were excluded due to missing data or follow-up. Finally, 369 HCC patients in the early stages were included in the analysis. After PSM, 168 patients were matched and there were 56 patients in each group

You may not qualify if:

• with any history of malignant tumors; with treatment of ablation, TACE or TKI history before liver resection.

Sponsors & Collaborators

• Chen Xiaoping: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

Hepatectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Xiaoping Chen, Dr

  Tongji Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 11, 2021
• Study Start: February 14, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

CN (1)