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

NCT ID: NCT06776185

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2024-11-15

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Liver Surgery

Intervention Type: 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

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.

Liver Surgery

Intervention Type: 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

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

Liver Surgery

Intervention Type: 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

Interventions

Liver 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chen Xiaoping

OTHER

Sponsor Role: lead

Responsible Party

Chen Xiaoping

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Wuhan Tongji Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

RLOCE-001

Identifier Type: -

Identifier Source: org_study_id