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3D preoperative liver resection planning and confirmation

3D preoperative liver resection planning and confirmation - 3D-PreLiveR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57000
Enrollment
20
Registered
2024-09-11
Start date
2024-11-28
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

liver cancer Malignent liver tumors

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who will undergo (partial) liver resection A contrast enhanced CT scan of sufficient quality for preoperative 3D reconstruction

Exclusion criteria

Exclusion criteria: Prior hepatectomy Patients unable to undergo additional contrast enhanced imaging, including those with contraindications for CT scans or contrast agents.

Design outcomes

Primary

MeasureTime frame
Main study endpoint is the feasibility of preoperative planning for surgical resection of liver tumors and the ability to compare post-operative 3D reconstruction of the hepatectomy results to the preoperative 3D surgical planning Endpoints are: - The number of patients in which the analysis was possible - Differences in preoperatively planned resection and margin measurements compared to the achieved resection and resection margins

Secondary

MeasureTime frame
Secondary study endpoints are assessment and correlation of the surgical margins as measured between 3D reconstructions to the histopathological margins, and evaluation of the process of creating the 3D preoperative planning, usability in determining resection plane and the ability to determine post-operative technical success and resection margins. Endpoints are: - Volumetric measurements of the resection margins on 3D reconstructions - Correlation and comparability between histopathological margins and margins measured on 3D reconstructions - Scoring of process of segmenting and creating the 3D models, and co-registering and assessing postoperative technical success.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)