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JPLT6

Multicenter prospective observational study to verify the feasibility of surgical planning system based on preoperative 3D simulation for pediatric and AYA patients with liver tumors: JPLT-6 - JPLT6

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1060240085
Enrollment
50
Registered
2024-11-14
Start date
2024-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric/AYA liver malignant tumors hepatoblastoma, HCN-NOS, hepatocellular carcinoma, intrahepatic cholangiocarcinoma, hepatic undifferentiated sarcoma

Interventions

None listed

Sponsors

Hiyama Eiso
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactSho Kurihara

Hiroshima University Hospital

s-kurihara@hiroshima-u.ac.jp+81-822575216

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026