Clinical trial NCT05327907: Establishment of Scoring Model for Early and Differential Diagnosis of Intrahepatic Cholangiocarcinoma
Official title: Establishment of Scoring Model for Early Diagnosis and Differential Diagnosis of Intrahepatic Cholangiocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: Intrahepatic cholangiocarcinoma
Hepatocellular carcinoma
radiomics
nomogram
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Jinan Central Hospital
name: Shandong Provincial Hospital
name: Jinan Military General Hospital
First posted: 2022-04-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy
timeFrame: through study completion, up to 2 years
measure: sensitivity
timeFrame: through study completion, up to 2 years
measure: specificity
timeFrame: through study completion, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology,Qilu Hospital,Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanjing Gao, PhD.MD
role: PRINCIPAL_INVESTIGATOR
References: