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

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.

Study Overview

• Status: Recruiting
• Conditions: Intrahepatic Cholangiocarcinoma

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Yanjing Gao, PhD.MD; Phone Number: 86-18560086087; Email: gaoyanjing@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology,Qilu Hospital,Shandong University
      • Contact: Yanjing Gao, PhD.MD; Phone Number: 86-18560086087; Email: gaoyanjing@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinical data of patients in hospitals in the past 10 years were retrospectively collected. Pathological database from September 2010 to July 2021 was searched. Patients with definite pathological diagnosis of ICC or HCC were determined as the training group, and patients from September 2021 to September 2023 were prospectively collected as the validation group.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Training cohort; Training cohort consists of the patients diagnosed with intrahepatic cholangiocarcinoma who collected from January 2010 to July 2021 retrospectively.
Internal validation cohort; Internal validation cohort consists of the intrahepatic cholangiocarcinoma patients who enrolled from September 2021 of Qilu Hospital prospectively.
External validation cohort; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: Shandong Provincial Hospital; Jinan Military General Hospital; Jinan Central Hospital
• Investigators: Principal Investigator: Yanjing Gao, PhD.MD, Qilu Hospital, Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2020
• Primary Completion (Anticipated): February 22, 2023
• Study Completion (Anticipated): May 22, 2023

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Hepatocellular carcinoma; nomogram; radiomics; Intrahepatic cholangiocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: 202135719-Qilu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No