Skip to main content
Clinical Trials/NCT05327907
NCT05327907
Unknown
Not Applicable

Establishment of Scoring Model for Early Diagnosis and Differential Diagnosis of Intrahepatic Cholangiocarcinoma

Qilu Hospital of Shandong University1 site in 1 country300 target enrollmentNovember 22, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intrahepatic Cholangiocarcinoma
Sponsor
Qilu Hospital of Shandong University
Enrollment
300
Locations
1
Primary Endpoint
Accuracy
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to develop and validate a radiological nomogram including radiological characteristics, clinical risk factors, and medical history. And we aim to establish a noninvasive method for the diagnosis of intrahepatic cholangiocarcinoma (ICC), and to construct a differential diagnosis model for ICC and hepatocellular carcinoma (HCC) with higher sensitivity and accuracy.

Detailed Description

In recent years, the incidence and mortality of intrahepatic cholangiocarcinoma (ICC) have been increasing worldwide. Due to the different treatment options for hepatocellular carcinoma (HCC) and ICC, accurate differential diagnosis is critical for subsequent treatment of patients. However, because of their similar CT image enhancement patterns, they are easily misdiagnosed by clinicians, leading to an incorrect treatment. Based on the above research background, our objective is to establish a noninvasive method for the diagnosis of ICC and and to construct a differential diagnosis model for ICC and HCC with higher sensitivity and accuracy.

Registry
clinicaltrials.gov
Start Date
November 22, 2020
End Date
May 22, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yanjing Gao

Clinical Professor

Qilu Hospital of Shandong University

Eligibility Criteria

Inclusion Criteria

  • patients with pathological confirmation of ICC or HCC,
  • CT was performed less than 15 days before surgery,
  • Patients with complete clinical data.

Exclusion Criteria

  • history of other tumors,
  • Metastatic liver cancer,
  • Patients received preoperative chemotherapy or radiotherapy,
  • Image quality analysis is not ideal.

Outcomes

Primary Outcomes

Accuracy

Time Frame: through study completion, up to 2 years

The golden standard is the pathological biopsy.Compare the accuracy of the noninvasive model with the pathological biopsy.

sensitivity

Time Frame: through study completion, up to 2 years

Sensitivity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.

specificity

Time Frame: through study completion, up to 2 years

Specificity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.

Study Sites (1)

Loading locations...

Similar Trials