Establishment of Scoring Model for Early Diagnosis and Differential Diagnosis of Intrahepatic Cholangiocarcinoma
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Accuracy
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Yanjing Gao
Clinical Professor
Qilu Hospital of Shandong University