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OpenTrials
Completed

NCT Number: NCT06776185

Recurrence Patterns and Cost-Effectiveness of Surgical Approaches in Early-Stage Hepatocellular Carcinoma

This study aims to investigate the recurrence patterns and cost-effectiveness of robotic-assisted, laparoscopic, and open liver resections in patients with early-stage (BCLC 0/A) hepatocellular carcinoma. By analyzing data from 3000 patients across 27 centers, the research evaluates recurrence-free survival, overall survival, and long-term economic impacts using metrics such as quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). Findings will provide insights into optimal surgical approaches to improve patient outcomes and healthcare resource utilization.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wuhan Tongji Hospital

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (1) HCC diagnosis confirmed by two independent radiologists using contrast-enhanced computed tomography (CT) and/or magnetic resonance imaging (MRI) combined with postoperative pathology; (2) BCLC stage 0 or A; and (3) curative liver resection

Exclusion criteria

  • (1) concurrent malignancies in other organs; (2) diagnosis of combined hepatocellular-cholangiocarcinoma; (3) prior neoadjuvant or adjuvant treatment before liver resection; (4) recurrent HCC; (5) ruptured HCC; and (6) incomplete follow-up or missing data.

Treatment and study plan

Liver Surgery

Procedure

Minimally Invasive Liver Resection In both LLR and RALR, standardized preoperative planning with 3D imaging was utilized to assess tumor location, size, and proximity to vascular structures, enabling precise port placement. Typically, four to five trocar ports were inserted based on the tumor's location, with adjustments as needed

Primary outcomes

  1. Recurrence-free Surival

    Time frame: 2017-01-01--2024-01-01

Sponsors and collaborators

Lead sponsor

Chen Xiaoping

Other

Registry information

Official study title

Recurrence Patterns and Cost-Effectiveness of Robotic-assisted, Laparoscopic, and Open Liver Resection in BCLC 0/A Hepatocellular Carcinoma:

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

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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