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

• Conditions: Intrahepatic Cholangiocarcinoma

• Registration Number: NCT05327907
• Lead Sponsor: Qilu Hospital of Shandong University

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 Timeline

• Study Start: 2020-11-22
• Status Verified: 2022-04
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-07
• Last Update Submitted: 2022-04-07
• Study First Posted: 2022-04-14
• Last Update Posted: 2022-04-14
• Primary Completion: 2023-02-22
• Study Completion: 2023-05-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Gastroenterology,Qilu Hospital,Shandong University; 🇨🇳 Jinan, Shandong, China