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.

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0008973
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 130

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

No other exclusion criteria

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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