RecruitingNot ApplicableNCT04678583

Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer


Sponsor

Technische Universität Dresden

Enrollment

240 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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
  • 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

Interventions

PROCEDUREResection of colorectal liver metastases

Comparison of two liver surgery methods


Locations(37)

Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University

Mannheim, Baden-Wurttemberg, Germany

Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden

Dresden, Saxony, Germany

Intestinal Center West Middle Franconia, ANregiomed Clinic Ansbach

Ansbach, Germany

Clinic for General, Vizeral and Transplant Surgery, Augsburg University Hospital

Augsburg, Germany

Department of General, Visceral and Vascular Surgery, Charité, University Medicine Berlin, Campus Benjamin Franklin Berlin

Berlin, Germany

Clinic and Polyclinic for General, Visceral, Thoracic and Vascular Surgery, University Hospital Bonn

Bonn, Germany

Surgical Clinic, Municipal Hospital Braunschweig gGmbH

Braunschweig, Germany

Cancer Center, Helios Amper-Hospital Dachau

Dachau, Germany

Surgical Clinic, Dortmund Hospital

Dortmund, Germany

Clinic for General and Visceral Surgery, Municipal Hospital Dresden

Dresden, Germany

Clinic for General, Visceral and Pediatric Surgery, University Hospital Düsseldorf

Düsseldorf, Germany

Surgical Clinic, University Hospital Erlangen

Erlangen, Germany

Clinic for General, Visceral and Transplant Surgery, University Hospital Frankfurt, Goethe University Frankfurt am Main

Frankfurt, Germany

Department for General and Visceral Surgery, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg

Freiburg im Breisgau, Germany

JLU Gießen, Department for General, Visceral, Thoracic and Transplant Surgery

Giessen, Germany

Clinic for General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Georg-August-University

Göttingen, Germany

Clinic and Polyclinic for General Surgery, Department of Gastrointestinal, Thoracic and Vascular Surgery, University Greifswald, University Hospital Greifswald

Greifswald, Germany

University Hospital and Polyclinic for Visceral, Vascular and Endocrine Surgery, University Hospital Halle (Saale)

Halle, Germany

Center for Surgical Medicine - Clinic and Polyclinic for General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf

Hamburg, Germany

Department of Liver, Bile Duct and Pancreas Surgery, University Department of surgery, Asklepios Klinik Barmbek

Hamburg, Germany

Clinic for General, Visceral and Minimally Invasive Surgery, KRH Clinic Siloah, Hannover

Hanover, Germany

Medizinische Hochschule Hannover, Department of General, Visceral and Transplant Surgery

Hanover, Germany

Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Heidelberg, Germany

General Visceral and Vascular Surgery, Jena University Medical Center

Jena, Germany

Clinic for Surgery, University Hospital Schleswig-Holstein Lübeck Campus

Lübeck, Germany

University Department of General, Visceral, Vascular and Transplant Surgery, Faculty of Medicine, Otto von Guericke University Magdeburg

Magdeburg, Germany

Clinic for General, Visceral and Transplantation Surgery, University Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Germany

Clinic for Visceral, Thoracic and Vascular Surgery, University Hospital Giessen and Marburg

Marburg, Germany

LMU Munich Hospital, Clinic for General, Visceral and Transplant Surgery

Munich, Germany

Department Hepato-Pancreato-Biliary Surgery, Barmherzige Brüder gGmbH of the Hospital Barmherzige Brüder Munich

München, Germany

Department of Surgery, University Hospital rechts der Isar

München, Germany

Clinic for General, Visceral and Transplant Surgery, University of Münster

Münster, Germany

University Hospital for General and Visceral Surgery, Oldenburg Hospital

Oldenburg, Germany

Department of General, Visceral and Transplant Surgery, University of Tübingen, Comprehensive Cancer Center

Tübingen, Germany

Clinic for General and Visceral Surgery, Ulm University Medical Center

Ulm, Germany

General and Visceral Surgery, Helios University Medical Center Wuppertal, University Witten/Herdecke

Wuppertal, Germany

Department for General, Visceral, Transplant, Vascular and Pediatric Surgery, Julius-Maximilian-University Würzburg, University Hospital Würzburg

Würzburg, Germany

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NCT04678583