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| Name | Class |
|---|---|
| Jinan Central Hospital | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Jinan Military General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanjing Gao, PhD.MD | Contact | 86-18560086087 | gaoyanjing@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanjing Gao, PhD.MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology,Qilu Hospital,Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |