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

NCT06776185 | Completed DMC

• 1 other identifier: RLOCE-001
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HCC - Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Recurrence-free Surival

  2017-01-01--2024-01-01

Study Arms (3)

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

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

Laparoscopic; Open Liver Resection; Robotic-assisted

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chen Xiaoping: lead

Study Sites (1)

Wuhan Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: January 15, 2022
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)