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

Shandong University

Status: Enrolling

Conditions: Intrahepatic Cholangiocarcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT05327907

202135719-Qilu

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

300 participants in 3 patient groups

Training cohort

Description:

Training cohort consists of the patients diagnosed with intrahepatic cholangiocarcinoma who collected from January 2010 to July 2021 retrospectively.

Internal validation cohort

Description:

Internal validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Qilu Hospital prospectively.

External validation cohort

Description:

External validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Shandong Province Hospital, Jinan Military General Hospital and Jinan Central Hospital prospectively.