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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07483242

Enrollment

151

Registered

2026-03-19

Start date

2024-08-01

Completion date

2025-08-01

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma (HCC)

Brief 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.

Interventions

PROCEDUREBile Duct Resection

This group includes biliary/enteric reconstruction, bile duct resection with thrombectomy, and biliary tract interventions

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

31 Years to 80 Years

Inclusion criteria

* Pathologically confirmed HCC with BDTT; * Absence of extrahepatic malignancies at the time of HCC diagnosis; * Undergone R0 curative hepatectomy; * No prior antitumor therapies, such as chemotherapy or immunotherapy, before surgery; * Availability of preoperative imaging (CT or MRI) with standardized tumor evaluation.

Exclusion criteria

* Pathological findings indicating concurrent cholangiocarcinoma and HCC; * Loss to follow-up, preventing outcome evaluation, or insufficient clinical data for analysis. * Significant comorbidities (e.g., severe cardiac or renal failure) that could affect surgical outcomes.

Design outcomes

Primary

Measure	Time frame	Description
Treatment Effects	2025.09.01	5-year overall survival (OS)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026