C78.7
Conditions
Interventions
Group 1: Intraoperative ICG fluorescence imaging (0.5 mg/kg IV, administered 3-7 days preoperatively)
fluorescence-guided minimally invasive liver resection.
Group 2: Standard minimally invasive liver resection without ICG administration
Sponsors
Uniklinik Magdeburg, Klinik für Allgemein-, Viszeral-, Gefäß- und Transplantationschirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Histologically or radiologically confirmed primary or secondary liver malignancy - Planned minimally invasive liver resection (robotic or laparoscopic) - Estimated glomerular filtration rate (eGFR) = 45 mL/min/1.73 m² - Existence of a written informed consent form
Exclusion criteria
Exclusion criteria: • Allergy or hypersensitivity to indocyanine green (ICG) or iodine-containing substances • Known hyperthyroidism or functional/autonomous thyroid disease • Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m² • Child–Pugh C liver cirrhosis • Technically or functionally unresectable tumors • Severe cognitive impairment affecting the ability to give informed consent • Pregnancy or breastfeeding • Participation in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHAT: R0 resection rate (defined as microscopically tumor-free resection margin in the histopathological examination of the resected specimen) WHEN: Assessment is performed postoperatively after the final histopathological report becomes available (typically within 7-14 days after surgery) HOW: Assessment by the pathologist based on standardized histopathological examination of the resection specimen according to institutional protocol. The pathologist is blinded to group assignment (ICG vs. control) and evaluates solely based on the pathological specimen whether the resection margins are tumor-free (R0) or whether microscopic tumor residue is present (R1/R2). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Intraoperative change in strategy • Detection of additional lesions • Complications according to Clavien–Dindo (including major complications) • Liver surgery-specific complications • Conversion rate (minimally invasive ? open) • Duration of surgery • Blood loss and transfusion requirements • Length of hospital stay • Perioperative morbidity and mortality (30 and 90 days) • 12-month survival (overall survival and recurrence-free survival) | — |
Countries
Germany
Contacts
Public ContactMirhasan Rahimli
Universitätsklinik für Allgemein-, Viszeral-, Gefäß- und Transplantationschirurgie
Outcome results
None listed