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Multicenter study for analyzing the impact of 3D modeling of liver in preoperative decision making and task loading of the surgeon and clinical outcome of the patient.

Multicenter study for analyzing the impact of 3D modeling of liver in preoperative decision making and task loading of the surgeon and clinical outcome of the patient.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008973
Enrollment
130
Registered
2023-11-24
Start date
2023-10-31
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

None listed

Interventions

Others(3D reconstructed image of liver based on medical images such as computed tomography or magnetic resonance imaging) : Through random allocation, patients are divided into the 3D modeling group a

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Hepatobiliary surgeons may determine the need for 3D modeling in cases where they are planning liver resection surgery due to malignant or benign tumors/diseases for the following reasons: 1) When the anatomical location of the tumor is challenging to assess in two dimensions, especially in the posterosuperior segments of the liver (segments 4, 7, and 8), where surgery can be more complex. In such cases, 3D modeling is considered helpful. (Reference: The IWATE criteria describe that surgery is more difficult in cases where the tumor is located in the posterosuperior segment compared to other locations.) 2) When the tumor is situated in proximity to blood vessels or in a complex position between vessels, such as within 1 cm of the hepatic vein's territory, portal vein's branching region, or inferior vena cava. In these instances, 3D modeling is deemed necessary to aid in defining the resection boundaries. 3) When the tumor is too small to be easily located during surgery, particularly if it measures 2 cm or less, and 3D modeling is believed to assist in accurately identifying its position. 4) In cases where the tumor is large, measuring 4 cm or more, and 3D modeling is considered necessary to establish the appropriate resection boundaries. 5) When determining the resection boundaries requires volumetric information about liver function and the remaining liver tissue, as seen in right hepatectomy, right anterior sectionectomy, right posterior sectionectomy, central hepatectomy, left hepatectomy, or more extensive surgeries, such as major hepatectomy. 6) In any other situations where 3D modeling is deemed necessary for reasons not covered above.

Exclusion criteria

Exclusion criteria: No other exclusion criteria

Design outcomes

Primary

MeasureTime frame
Preoperative surgical planning (Planned surgical extent and whether minimal invasive surgery will be applied);The actual surgery performed (resection name and whether minimal invasive surgery was done);NASA task load index

Secondary

MeasureTime frame
Surgical information includes details such as the duration of the surgery, whether it is performed laparoscopically, whether the Pringle's maneuver is employed, the extent of bleeding during surgery, the need for blood transfusion, the type and quantity of transfused components (e.g., red blood cells, white blood cells, fresh frozen plasma), the use of vasopressors during surgery, the name of the surgical procedure, and the safety margin around the tumor and resection area.;Pathological information including the number of tumors, tumor size, the presence of liver fibrosis, details related to liver cancer (pathological malignancy, microvascular invasion, vascular invasion, intrahepatic metastasis, lymph node involvement, bile duct invasion), and staging.;Post-operative progress, changes in blood test results after surgery (hemoglobin, platelet count, prothrombin time, creatinine, albumin, total bilirubin, AST, ALT), the length of the hospital stay until discharge, the need for post-operative blood transfusion, the amount of pain medication used, the occurrence and severity of complications, and the possibility of readmission or reoperation.

Countries

Korea, Republic of

Contacts

Public ContactJinsoo Rhu

Samsung Medical Center

jsrrules@gmail.com+82-2-3410-3479

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026