A Study on Intratumoral Fibrosis and α-SMA Expression in Intrahepatic Cholangiocarcinoma

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

MRI-Based Radiomics and Machine Learning for Preoperative Assessment of Intratumoral Fibrosis and α-Smooth Muscle Actin Expression in Intrahepatic Cholangiocarcinoma

The aim of this observational study was to understand the prognostic imaging of the degree of intratumoral fibrosis and intratumoral α-SMA levels in patients with intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are:

Whether the degree of intratumoral fibrosis and the level of intratumoral α-SMA affect the overall survival and progression-free survival of ICC patients.

Participants will be surveyed for survival and tumor recurrence up to 5 years after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intrahepatic cholangiocarcinoma (ICC), which originates from the proximal secondary bile duct in the liver parenchyma (based on the direction of bile flow), is the second most common type of primary liver cancer after hepatocellular carcinoma, accounting for 10-20% of all primary liver cancers. In recent years, the incidence and mortality of ICC have been increasing in most regions of the world. α-SMA-positive CAFs in ICC may aggravate tumor progression and reduce survival time, which is a significant prognostic indicator. However, the evaluation of α-SMA expression level in previous studies mostly relied on subjective evaluation by pathologists after visual observation, and there was a lack of quantitative indicators. In addition, there are differences in the effect of intratumoral fibrosis on the prognosis of ICC, and there may be an interactive relationship between the expression of α-SMA and intratumoral fibrosis. The effect of intratumoral α-SMA expression level and fibrosis on the prognosis of ICC still deserves further exploration. Therefore, the aim of this study is to investigate the relationship between the expression level of α-SMA and the degree of fibrosis in ICC and Progression-free survival (PFS) and Overall survival (OS) by survival analysis. To determine the expression level of α-SMA and the risk degree of fibrosis in ICC.

Study Type

Observational

Enrollment (Actual)

169

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, 510080
        • The First Affiliated Hospital, Sun Yat-sen University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with single ICC who underwent radical partial hepatectomy in our hospital from January 2018 to January 2024 were retrospectively enrolled in this study.

Description

Inclusion Criteria:

  • Patients who underwent radical resection of liver tumors in our center and obtained surgical specimens;
  • ICC was diagnosed by postoperative pathology

Exclusion Criteria:

  • Patients had received radiotherapy, chemotherapy, intervention and other treatments for liver tumors before surgery
  • The tumor sections could not be obtained due to the loss of wax blocks or most of the defects of pathological specimens
  • No upper abdominal Gd-EOB-DTPA-enhanced MRI examination in our center within one month before surgery
  • Poor image quality or incomplete image data

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
intratumoral high-fibrosis group
Other: No Interventions
Only the degree of intratumoral fibrosis and the expression of α-SMA in the postoperative pathological specimens of ICC patients were observed, without intervention measures.
intratumoral low-fibrosis group
Other: No Interventions
Only the degree of intratumoral fibrosis and the expression of α-SMA in the postoperative pathological specimens of ICC patients were observed, without intervention measures.
α-SMA high-expression group
Other: No Interventions
Only the degree of intratumoral fibrosis and the expression of α-SMA in the postoperative pathological specimens of ICC patients were observed, without intervention measures.
α-SMA low-expression
Other: No Interventions
Only the degree of intratumoral fibrosis and the expression of α-SMA in the postoperative pathological specimens of ICC patients were observed, without intervention measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Effects
Time Frame: From the time of the patient's surgery to the end of the 5-year follow-up
5-year overall survival (OS)
From the time of the patient's surgery to the end of the 5-year follow-up

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)

January 1, 2018

Primary Completion (Actual)

January 17, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUFAH20260311
  • 82471948 (Other Grant/Funding Number: National Natural Science Foundation of China)

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.

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