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

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327907
• Other study ID #: 202135719-Qilu
• Status: Recruiting
• Start date: November 22, 2020
• Est. completion date: May 22, 2023

Study information

• Verified date: April 2022
• Source: Qilu Hospital of Shandong University
• Contact: Yanjing Gao, PhD.MD
• Phone: 86-18560086087
• Email: gaoyanjing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 22, 2023
• Est. primary completion date: February 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Locations

Country	Name	City	State
China	Department of Gastroenterology,Qilu Hospital,Shandong University	Jinan	Shandong

Sponsors (4)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	Jinan Central Hospital, Jinan Military General Hospital, Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	The golden standard is the pathological biopsy.Compare the accuracy of the noninvasive model with the pathological biopsy.	through study completion, up to 2 years
Primary	sensitivity	Sensitivity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.	through study completion, up to 2 years
Primary	specificity	Specificity of noninvasive model for diagnosis of intrahepatic cholangiocarcinoma.	through study completion, up to 2 years