Individualized Surgical Guidance in HCC-BDTT

March 16, 2026 updated by: Xu Danyang, First Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

151

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • China, Guangdong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

This dual-center observational study was approved by the Institutional Review Board (IRB) of the First Affiliated Hospital of Sun Yat-sen University (approval number: [2023]016), with a waiver of informed consent. This study retrospectively enrolled patients with HCC from two campuses: Yuexiu campus (Center 1; January 2011-August 2020) and Huangpu campus (Center 2; August 2014-August 2020).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bile Duct Resection (BDR) group
Procedure: Bile Duct Resection
This group includes biliary/enteric reconstruction, bile duct resection with thrombectomy, and biliary tract interventions
Non-Bile Duct Resection (NBDR) group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Effects
Time Frame: 2025.09.01
5-year overall survival (OS)
2025.09.01

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

August 1, 2025

Study Registration Dates

First Submitted

March 8, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUFAH20251021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All primary data are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma (HCC)

Clinical Trials on Bile Duct Resection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe