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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05327907

Enrollment

300

Registered

2022-04-14

Start date

2020-11-22

Completion date

2023-05-22

Last updated

2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

Intrahepatic cholangiocarcinoma, Hepatocellular carcinoma, radiomics, nomogram

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy	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	through study completion, up to 2 years	Sensitivity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.
specificity	through study completion, up to 2 years	Specificity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.

Countries

China

Contacts

Primary ContactYanjing Gao, PhD.MD

gaoyanjing@sdu.edu.cn86-18560086087

Outcome results