Abdominal Injury, Abdominal Neoplasm, Ascites
Conditions
Brief summary
The goal of this clinical trial is to evaluate the application of intravenous contrast-enhanced ultrasound examination in children with intra-abdominal diseases that require clear diagnoses. The main questions it aims to answer are: * Is intravenous contrast-enhanced ultrasound helpful for the diagnosis of intra-abdominal diseases in children? * What medical problems do participants have when participating in intravenous contrast-enhanced ultrasound examination? * How can ultrasound doctors conduct intravenous contrast-enhanced ultrasound examinations in a standardized manner? Researchers will performing intravenous contrast-enhanced ultrasound examinations on participants and collecting research subjects to establish a multicenter clinical data database. Participants will: * Perform abdominal ultrasound examination to assess the condition. * At least conduct one intravenous contrast-enhanced ultrasound examination. Based on the result of the contrast examination, decide whether to conduct another examination. * Keep a diary of their symptoms and therapeutic process in 30 days.
Interventions
DEVICEcontrast-enhanced ultrasound examination
to evaluate the the application of contrast-enhanced ultrasound examination in children with intra-abdominal diseases that require clear diagnoses aged from 29 days to 18 years old
DRUGSonoVue®
perform contrast enhanced ultrasound (CEUS) using Sonovue as the contrast agent
Sponsors
Shenzhen Children's Hospital
Children's Hospital of Chongqing Medical University
Tianjin Children's Hospital
Kunming Children's Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
West China Hospital
Yuying Children's Hospital of Wenzhou Medical University
Xian Children's Hospital
The Children's Hospital of Zhejiang University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
29 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age 29 days to 18 years old; 2. The clinical diagnosis was abdominal space-occupying lesions, blunt abdominal trauma, ascites of unknown cause, and children with suspected abdominal disease but other examinations could not identify the cause.
Exclusion criteria
1. Allergic to sulfur hexafluoride or other components; 2. Heart disease with right-to-left shunt/severe pulmonary hypertension /uncontrolled systemic hypertension/respiratory failure/heart failure/severe arrhythmia; 3. Electrocardiogram, echocardiography or clinical manifestations of myocardial ischemia; 4. Patients with severe blood system diseases or infectious diseases; 5. Hypercoagulable state and recent history of thrombosis; 6. Severe hepatic and renal insufficiency; 7. Patients with respiratory tract infection or congenital respiratory malformation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sensitivity | Thirty days after the last venous ultrasound contrast examination | to calculate the sensitivity of venous contrast-enhanced ultrasound examination in children |
| specificity | Thirty days after the last venous ultrasound contrast examination | to calculate the specificity of venous contrast-enhanced ultrasound examination in children |
| Positive predictive value | Thirty days after the last venous ultrasound contrast examination | to calculate the positive predictive value of venous contrast-enhanced ultrasound examination in children |
| Negative predictive value | Thirty days after the last venous ultrasound contrast examination | to calculate the negative predictive value of venous contrast-enhanced ultrasound examination in children |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse event rate | Thirty days after the last venous ultrasound contrast examination | to calculate the adverse event rate of venous contrast-enhanced ultrasound examination in children |
Countries
China
Contacts
Primary ContactYE JJ Director of the Ultrasound Department
Outcome results
None listed