Colorectal liver metastases
Conditions
Interventions
Group 1: anatomical resection of liver metastases (almost complete removal of the affected liver segment)
Group 2: non-anatomical resection of liver metastases (removal of the liver metastases with a
Sponsors
Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Carl Gustav Carus an der Technischen Universität DresdenAnstalt des öffentlichen Rechts des Freistaates Sachsen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Colorectal cancer with RAS mutation (KRAS or NRAS) • Colorectal liver metastases (single or multiple) • Planned R0 resection of liver metastases (and primary tumor, if present) • Anatomical and non-anatomical liver resection technically feasible • Male and female patients, age = 18 years • Written informed consent
Exclusion criteria
Exclusion criteria: • Extrahepatic metastases (Exceptions: patients with resectable, irradiable or ablatable extrahepatic metastases. Please note, that patients that are treated in palliative intention cannot participate in the study.) • Planned staged liver resection (e.g. two-stage hepatectomy) • Diagnosis of another cancer < 5 years prior to randomization Exceptions: curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer • Expected lack of compliance • Addiction or other illnesses which do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intrahepatic disease-free survival (iDFS): Time from operation date to date of disease recurrence in the liver, followed up at intervals of three months for a maximum duration of 24 months or until death. Any new, solid lesion in the liver after resection of all CRLM that fulfils imaging criteria (CT, MRI) of a metastasis is counted as an iDFS event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of additional oncological and perioperative outcomes 1. Intraoperative blood loss [mL] (Intraoperative blood loss presents the amount of blood lost from skin incision until skin closure. Spilling water and ascites will be subtracted. Swabs will be squeezed and their content will also be sucked and added to the fluid collected in the suction containers. / during surgery) 2. Operating time [min] (Time from skin incision until placement of last skin staple/suture. / during surgery) 3. Transfusion of blood, transfused packed red blood cells (PRBC), fresh frozen plasma (FFP) and / or platelet concentrate (PC) [units] (Administration of blood transfusions is documented for the intra- and postoperative period within 48 hours postoperatively.) 4. Duration of postoperative hospital stay [days] (Postoperative day 1 until day of discharge) 5. Duration of postoperative intermediate/intensive care unit stay [days] (Days on the intermediate care unit (IMC) or intensive care unit (ICU) after surgery. Patient's stay in the recovery room exceeding 24 hours is counted as ICU stay. / postoperative day 1 until day of discharge) 6. Frequency and kind of peri-operative morbidity after resection (Frequency of peri-operative complications after resection of the primary tumor until 90 days after surgery. Complications are graded according to Clavien-Dindo-classification) 7. 90-day mortality (Death due to any cause within 90 days after surgery) 8. Liver biochemical tests (Platelet count and levels of alanine-aminotransferase (ALT), aspartate-aminotransferase (AST), gamma-glutamyl transferase (GGT), international normalized ratio (INR), total bilirubin, and albumin will be measured preoperatively and on postoperative day 5.) 9. Frequency and kind invasive re-interventions (Invasive re-interventions such as placement of interventional drains, Endoscopic retrograde cholangiopancreatography (ERCP) with stent placement, chest tube placement, and re-laparotomy w | — |
Countries
Germany
Contacts
Public ContactStudienzentrum VTG
Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Carl Gustav Carus an der Technischen Universität DresdenAnstalt des öffentlichen Rechts des Freistaates Sachsen
Outcome results
None listed