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

NCT07479264 | Completed DMC

• 2 other identifiers: SYSUFAH2026031182471948
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrahepatic Cholangiocarcinoma (Icc)

Keywords

Intrahepatic cholangiocarcinoma; MRI; Intratumoral fibrosis; α-SMA; Prognosis

Outcome Measures

Primary Outcomes (1)

• Treatment Effects

  5-year overall survival (OS)

  From the time of the patient's surgery to the end of the 5-year follow-up

Study Arms (4)

intratumoral high-fibrosis group

Other: No Interventions

intratumoral low-fibrosis group

Other: No Interventions

α-SMA high-expression group

Other: No Interventions

α-SMA low-expression

Other: No Interventions

Interventions

No Interventions OTHER

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 high-fibrosis group; intratumoral low-fibrosis group; α-SMA high-expression group; α-SMA low-expression

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 18, 2026
• Study Start: January 1, 2018
• Primary Completion: January 17, 2025
• Study Completion: May 1, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CN (1)