the ARMANI trial will test the hypothesis, if an anatomic resection (AR) improves long-term outcome vs. a non-anatomical resection (NAR) in patients undergoing surgery for RAS-mutated colorectal liver metastasis (CRLM).
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
Extrahepatic metastases
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
Parallel
Resection of colorectal liver metastases
Procedure/SurgeryComparison of two liver surgery methods
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.
Assessment of additional oncological and perioperative outcomes: 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.
Assessment of additional oncological and perioperative outcomes: Operating time [min]
Time from skin incision until placement of last skin staple/suture.
Assessment of additional oncological and perioperative outcomes: 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.
Assessment of additional oncological and perioperative outcomes: Duration of postoperative hospital stay [days]
Postoperative day 1 until day of discharge
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Technische Universität Dresden
Lead sponsor
German Cancer Research Center
Collaborator
