Exploration of Noninvasive Differential Diagnosis of Benign and Malignant Liver Tumors

Recruiting

• Conditions: Liver Tumor
• Interventions: Diagnostic Test: with chronic liver disease

• Registration Number: NCT06524557
• Lead Sponsor: Xijing Hospital

Brief Summary

To explore an effective noninvasive method for differential diagnosis of liver tumors.

Detailed Description

A retrospective study was performed to assess the performance of certain ultrasound-based parameters, in distinguishing benign from malignant with liver biopsy as the gold standard. Demographic data, clinical information and serological data were obtained from participants who were retrospectively enrolled. Receiver operating characteristic (ROC) curve analysis was conducted, including calculation of the optimal area under the ROC curve (AUC), to assess the performance of these measures in distinguishing between benign and malignant in patients with or without chronic liver disease.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

(1) age 18-70 years; (2) liver examination performed for all patients prior to US-guided liver biopsy or surgery; (3) tumor can be visualized in conventional US; (4) largest tumor sectional area saved in DICOM format for use in later analyses; (5) a histopathological diagnosis made either from US-guided liver biopsy or surgical resection; (6) suitable routine clinical and US data obtained within 7 days of the histopathological diagnosis.

Exclusion Criteria

(1) unavailable pathological diagnosis; (2) liver metastatic tumors; (3) poor quality US images; and (4) a past history of surgical resection, percutaneous local ablation, radiation, transarterial and systemic therapies or liver transplantation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with chronic liver disease	with chronic liver disease	patients with hepatitis B virus, hepatitis C virus and other chronic liver disease.

Primary Outcome Measures

Name	Time	Method
The differential diagnosis of liver tumors	2018.01-2025.12	Multimodal ultrasound is of great value in the differential diagnosis of liver tumors

Trial Locations

Locations (1)

Xijing Hosptial; 🇨🇳 Xi'an, Xi'an, China