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CompletedNCT06776185Updated Jan 15, 2025

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

An observational study in HCC - Hepatocellular Carcinoma, sponsored by Chen Xiaoping. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-15.

Sponsored by Chen Xiaoping · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,000
Ages
18 Years to 80 Years
Sex
All
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Study summary

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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Conditions studied

  • HCC - Hepatocellular Carcinoma
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 3,000 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Chen Xiaoping is the lead sponsor of 17 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This multicenter study included BCLC stage 0/A HCC patients who underwent RALR, LLR, or OLR across 27 centers from July 2017 to July 2019

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Robotic-assisted

    RALR was conducted using a robotic platform, which allowed for precise dissection and 3D visualization. Robotic arms equipped with advanced energy devices facilitated delicate maneuvers, particularly in deep or difficult-to-access segments. A 3D liver model was displayed on the robotic console, enabling real-time reference during dissection. As with LLR, intraoperative ultrasound refined the tumor boundaries, and the Pringle maneuver was selectively applied when necessary.

    Procedure: Liver Surgery

  • Laparoscopic

    LLR was performed using standard laparoscopic instruments, with the surgeon directly manipulating instruments for tumor resection. Intraoperative ultrasound was routinely used to confirm tumor boundaries and refine resection margins, particularly for tumors adjacent to major vascular structures. During parenchymal transection, energy devices such as laparoscopic bipolar coagulators or ultrasonic scalpels were used to minimize blood loss. The Pringle maneuver was available as needed to control bleeding.

    Procedure: Liver Surgery

  • Open Liver Resection

    Open liver resection was typically performed through a right subcostal incision, extended to the midline if necessary to enhance liver access. The liver was mobilized by dividing surrounding ligaments, including the falciform, coronary, and triangular ligaments, to ensure optimal exposure of the tumor. Intraoperative ultrasound was used to confirm the exact tumor location, delineate resection margins, and detect any additional satellite nodules or vascular invasion not identified preoperatively. The Pringle maneuver, involving intermittent clamping of the portal triad, was selectively applied to control blood loss during parenchymal transection. Based on tumor characteristics, anatomical resections aimed to remove full segments, while non-anatomical resections focused on achieving negative margins (R0 resection) with minimal liver removal. Large tumors, central lesions, or cases requiring complex vascular reconstruction were typically managed with the open approach due to its direct a

    Procedure: Liver Surgery

Interventions

  • ProcedureLiver Surgery

    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

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What researchers measure

Primary outcomes

  1. Recurrence-free Surival

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

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Study locations

1 site
  • Wuhan Tongji Hospital
    Wuhan, Hubei 430030, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06776185
Lead sponsor
Chen Xiaoping
Responsible party
Chen Xiaoping (Professor, Tongji Hospital) — Sponsor-investigator
First posted
Jan 15, 2025
Start date
Jan 15, 2022
Primary completion
Nov 15, 2024
Completion
Nov 15, 2024
Last update
Jan 15, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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