Resection of colorectal liver metastases
ProcedureComparison of two liver surgery methods
NCT Number: NCT04678583
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).
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Request Info18 year and older
All sexes
Interventional
Not applicable
Department of Surgery at the University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Baden-Wurttemberg, Germany
Despite increasing application and success of personalized treatment in medical oncology, little progress has been made in personalized surgical cancer therapy. The ARMANI trial presents the first prospective, randomized trial to evaluate effectiveness and safety of molecular-guided resection in patients with colorectal liver metastasis (CRLM). While CRLM might be removed independently of the liver's segmental borders, retrospective data favor anatomic resections in the subgroup of patients with a mutation in the RAS oncogene. Therefore, 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 CRLM. The trial will be carried out among 11 high-volume centers of hepato-biliary surgery in Germany. A total of 220 patients will be enrolled and randomized in a 1:1 ratio to undergo an AR vs. NAR. The primary endpoint is intrahepatic disease-free survival (iDFS). In addition, the study will provide important data on perioperative outcomes and quality of life for both surgical techniques. Given the trend among liver surgeons to aim for parenchymal-sparing operations to preserve liver parenchyma, a positive trial will be practice changing and present the first piece of high-level evidence on benefits of personalized surgical therapy guided by the tumor's mutational profile in patients with CRLM.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparison of two liver surgery methods
Time frame: 24 months
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.
Time frame: During surgery
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.
Time frame: During surgery
Time from skin incision until placement of last skin staple/suture.
Time frame: 48 hours after surgery
Administration of blood transfusions is documented for the intra- and postoperative period within 48 hours postoperatively.
Time frame: At day of discharge, assessed up to 90 days
Postoperative day 1 until day of discharge
Time frame: At day of discharge, assessed up to 90 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
Time frame: 90 days after surgery
Frequency of peri-operative complications after resection of the primary tumor
Time frame: 90 days after surgery
Kind of peri-operative complications after resection of the primary tumor
Time frame: 90 days after surgery
Death due to any cause within 90 days after surgery
Time frame: pre-operatively, 5 days after surgery
Platelet count will be measured preoperatively and on postoperative day 5
Time frame: pre-operatively, 5 days after surgery
Levels of alanine-aminotransferase (ALT) will be measured preoperatively and on postoperative day 5
Time frame: pre-operatively, 5 days after surgery
Levels of aspartate-aminotransferase (AST) will be measured preoperatively and on postoperative day 5
Time frame: pre-operatively, 5 days after surgery
Levels of Gamma-glutamyl transferase (GGT) will be measured preoperatively and on postoperative day 5
Time frame: pre-operatively, 5 days after surgery
Levels of international normalized ratio (INR) will be measured preoperatively and on postoperative day 5
Time frame: pre-operatively, 5 days after surgery
Levels of total bilirubin will be measured preoperatively and on postoperative day 5
Time frame: pre-operatively, 5 days after surgery
Levels of albumin will be measured preoperatively and on postoperative day 5
Time frame: 30 days after surgery
Invasive re-interventions such as placement of interventional drains, Endoscopic retrograde cholangiopancreatography (ERCP) with stent placement, chest tube placement, and re-laparotomy within 30 days after the index operation or during patients' initial hospital stay
Time frame: 30 days after surgery
Invasive re-interventions such as placement of interventional drains, Endoscopic retrograde cholangiopancreatography (ERCP) with stent placement, chest tube placement, and re-laparotomy within 30 days after the index operation or during patients' initial hospital stay
Time frame: During surgery
Detection of tumor at the resection margin will be counted as positive resection margin
Time frame: 24 month
The overall survival of all patients is assessed between operation date to date of death of any cause
Time frame: 24 months
The cancer-specific survival of all patients is assessed between operation date to date of death of colorectal cancer
Time frame: 24 month
The disease-free survival of all patients is assessed from operation date to the date of either progressive or recurrent disease, or death of any cause
Time frame: 24 month
Adjuvant therapy is not recommended. However, the decision for adjuvant therapy is left at discretion of the local oncologist. The administration of adjuvant therapy and kind of chemotherapy protocols used will be documented for both groups.
Time frame: 24 month
Frequency of interventions for treatment of intra- and/or extrahepatic disease recurrence will be documented. These interventions include: Chemotherapy, Surgical resection, Local ablation (e.g. radiofrequency or microwave ablation, stereotactic irradiation), Selective internal radiotherapy (SIRT), other
Time frame: 24 month
Kind of interventions for treatment of intra- and/or extrahepatic disease recurrence will be documented. These interventions include: Chemotherapy, Surgical resection, Local ablation (e.g. radiofrequency or microwave ablation, stereotactic irradiation), Selective internal radiotherapy (SIRT), other
Time frame: 12 month
Quality of life is measured preoperatively and at 90 days (± 7 days) and 12 months (± 7 days) postoperatively using the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer; Questionnaire for the assessment of Quality of Life of Cancer patients with the module dedicated to colorectal liver metastases (EORTC QLQ-LMC21); the questionnaire assesses multi-item scales, each item scoring from 1 to 4, a high score represents a high level of symptomatology or problems.
Contact information is provided by the study sponsor or research team.
Technische Universität Dresden
Other
Acronym: ARMANI
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