NCT07297615

Brief Summary

The study aims to improve preoperative evaluation of liver resection volume in patients undergoing major hepatectomies. Accurate prediction of the planned resection and the future liver remnant (FLR) is critical to minimize the risk of postoperative liver failure, which is associated with increased morbidity and mortality. Conventional imaging-based volumetry may have limited accuracy. This study investigates the use of individualized 3D liver models combined to enhance visualization and volumetric analysis of liver anatomy and resection boundaries. Patients are recruited in the liver outpatient clinic and, upon consent, preoperative 3D models are created using Medics 3D. During surgery, the planned resection is guided by the individualized 3D models. Postoperatively, the resected specimen undergoes CT-based volumetry to compare the predicted resection volume from the 3D model with the actual volume. Routine postoperative follow-up is conducted. The study aims to optimize surgical planning, enhance the accuracy of future liver remnant prediction.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
29mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Sep 2028

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

December 9, 2025

Last Update Submit

February 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of the preoperative volumetry of the liver portion planned for resection using a 3D model and comparison with the postoperative resection specimen volume.

    Approximately 2-3 weeks are required between preoperative volumetry and postoperative volumetry comparison.

Study Arms (1)

Volumetry through 3D reconstruction

EXPERIMENTAL

Preoperative liver volumetry using individualized 3D reconstructions to guide major hepatectomy, optimize resection planning, and improve prediction of the future liver remnant.

Diagnostic Test: 3d reconstruction

Interventions

3d reconstructionDIAGNOSTIC_TEST

Preoperatively, every patient in this study will undergo an individualized 3D reconstruction of their liver to perform accurate volumetry.

Volumetry through 3D reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥18 years) undergoing open or minimally invasive major liver resection at the Clinical Division of General, Visceral and Transplant Surgery who provide written informed consent prior to participation will be included.

You may not qualify if:

  • Patients unable to provide informed consent will be excluded.
  • Minor resections.
  • Contraindications to MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz - Department of Surgery, Division of General, Visceral and Transplantationsurgery

Graz, Austria

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations