NCT07483242

Individualized Surgical Guidance in HCC-BDTT

Individualized Surgical Guidance for Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: A Causal Modeling Study Integrating Preoperative Imaging and Clinical Features

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 151 (actual)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 31 Years – 80 Years
• Healthy volunteers: —

Summary

The Rboost causal model can identify patients who are most likely to benefit among HCC-BDTT patients. Adherence to the individualized recommendation improves survival. This data-driven tool offers vital support for precision surgical decision-making in this high-risk disease.

Detailed description

This dual-center study recruited 151 HCC-BDTT patients who underwent radical hepatectomy (training cohort: 92; validation cohort: 59). An XGBoost-based R-learner (Rboost) algorithm was developed to estimate the individualized treatment effect (ITE) on 5-year overall survival (OS) between BDR and NBDR. Patients were stratified into ITE tertiles: BDR-recommended, ambiguous benefit, and NBDR-recommended. Model performance assessed with heterogeneity metrics (C-for-benefit, adjusted Qini index). Survival outcomes were compared within ITE strata between surgeries concordant and discordant with model recommendations (Kaplan-Meier/log-rank). Two-year disease-free survival (DFS) served as a treatment-proximal validity check.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
PROCEDURE	Bile Duct Resection	This group includes biliary/enteric reconstruction, bile duct resection with thrombectomy, and biliary tract interventions

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-06-01
• Completion: 2025-08-01
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: China