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Surgical Mapping with Advanced 3D-Reconstruction in Minimally Invasive Liver Surgery

Surgical Mapping with Advanced 3D-Reconstruction in Minimally Invasive Liver Surgery - SMART-MILS Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039587
Enrollment
126
Registered
2026-03-11
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Liver surgery, liver malignancies, surgical planning

Interventions

Group 1: Intervention arm: Advanced preoperative 3D-reconstruction of CT and/or MRI pictures for pre- and intraoperative surgical mapping and navigation. Group 2: Control arm: Standard minimally invas

Sponsors

Uniklinik RWTH Aachen, Klinik für Allgemein-, Viszeral-, Kinder- & Transplantationschirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Indication for elective liver resection (benign or malignant disease) 2. Availability of contrast-enhanced preoperative CT and/or MRI suitable for 3D reconstruction 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Emergency liver surgery 2. Liver transplantation or living donor hepatectomy 3. Previous major liver resection 4. Preoperative known necessity of further extrahepatic resections or extensive adhesolysis 5. Inability to provide informed consent 6. Current institutionalization on court or official order 7. Current or planned Pregnancy preoperatively

Design outcomes

Primary

MeasureTime frame
Operative time, defined as the time from first cutaneous incision to final suture, measured in minutes.

Secondary

MeasureTime frame
Secondary endpoints include surgeon stress level (self-reported stress-level; salivary cortisol sampling), intraoperative blood loss, rate of R0 resection in oncological cases, extent of resection beyond the tumor margins (exploratory endpoint by synchrotron-based phase-contrast imaging), surgeons stress and anxiety levels and cost-effectiveness of pre- and intraoperative 3D mapping.

Countries

Germany

Contacts

Public ContactNils Laurenz, B.Sc.

Uniklinik RWTH Aachen, Studienzentrum der Klinik für Allgemein-, Viszeral-, Kinder- & Transplantationschirurgie

nlaurenz@ukaachen.de+49 241 80 35670

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jul 25, 2026