This single-center, prospective, randomized clinical trial is designed to compare the clinical characteristics and outcomes of hepatic resection and microwave ablation (MWA) to determine the optimal operative intervention for the local treatment of resectable colorectal cancer liver metastases. The primary aim of this study is to test the following hypothesis: 2-year local disease control is equivalent between patients receiving the experimental therapy (MWA) and patients receiving the standard therapy (hepatic resection) as treatment for colorectal cancer liver metastases determined to be resectable by radiographic imaging. Secondarily, the investigators expect that 2-year intrahepatic (regional) and metastatic disease recurrence rates are equivalent between the two treatment arms in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1
Laparoscopic or robot-assisted laparoscopic microwave ablation of cancerous lesions with a 2.45-GHz microwave generator and a 1.8-mm-diameter transcutaneous antenna.
Laparoscopic or robot-assisted laparoscopic surgical resection of cancerous lesions.
Carolinas Medical Center
Charlotte, North Carolina, United States
Local disease control at the site of intervention
Local disease control is measured from time of randomization and is defined as the absence of local recurrence of metastatic adenocarcinoma of the colon or rectum as determined by diagnostic imaging.
Time frame: 2 years
Overall survival
Time frame: 1, 2, 3, 5 years
Intrahepatic disease-free survival
Time frame: 1, 2, 3, 5 years
Postoperative morbidity
Time frame: 1 month and 3 months
Postoperative mortality
Time frame: 1 month and 3 months
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