JPLT6

JRCT ID: jRCT1060240085

Registered date:14/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pediatric/AYA liver malignant tumors
• Date of first enrollment: 01/12/2024
• Target sample size: 50
• Study type: Observational

Outcome(s)

Primary Outcome

1. Percentage of cases for which recommended liver resection techniques can be constructed by submitting CT and MRI images for 3D construction, their ages, and PRETEXT/POSTEXT classification ratios used for staging of childhood liver cancer
2. Turnaround time from image submission to return of constructed image of 3D simulation image (number of days in working time from image submission to presentation of recommended surgical procedure)

Secondary Outcome

1. Concordance rate between blood vessels and tumor-occupied areas based on 3D simulation images and these locations after surgery
2. Operation time, blood loss, and postoperative complications of 3D simulation image construction example surgery
3. Local recurrence, distant metastatic recurrence, and 2-year disease-free survival rate of patients who underwent surgery after 3D simulation image construction

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 40age old

Include criteria

1. Diagnosed or suspected to have a non-treated pediatric/AYA malignnat liver tumors (hepatoblastoma, HCN-NOS, hepatocellular carcinoma, intrahepatic cholangiocarcinoma, hepatic undifferentiated sarcoma, etc.).
2. Less thjan 40 years old at diagnosis.
3. Written informed consent has been obtained from the patient or legal guardian.
4. Consent has been obtained for central pathological diagnosis and 3D simulation construction in solid tumor observation research, and consent has been obtained for submission of clinical information, etc.
5. Image data can be sent at the time of diagnosis (before treatment begins) and during treatment.
6. Recorded images during the surgery or a portion of them (one that shows the resection site) can be submitted along with the surgical procedure performed.
7. Clinical, imaging, and pathological findings can be sent at the time of diagnosis, during treatment, and after treatment.

• Exclude criteria: If the research director or co-researchers determine that participation in this research is inappropriate

Related Information

• Primary Sponsor: Hiyama Eiso
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development