Colorectal Neoplasms, Hepatic Neoplasms, Neoplasm Metastasis
Conditions
Keywords
Microwave ablation, Ablation techniques, Operative surgical procedures, Hepatic resection, Surgery, Outcomes assessment
Brief summary
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.
Interventions
PROCEDUREMicrowave ablation
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.
PROCEDUREHepatic resection
Laparoscopic or robot-assisted laparoscopic surgical resection of cancerous lesions.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of adenocarcinoma of the colon or rectum (diagnosed at the time of colon or rectal resection or on endoscopic biopsy) with liver metastases (by liver biopsy or by history of biopsy-proven colon/rectal cancer with characteristic imaging findings): * Imaging showing typical features of colorectal cancer liver metastasis; * Cytologic/histologic diagnosis of colorectal cancer or colorectal cancer liver metastasis. * No more than 3 hepatic metastatic lesions noted on preoperative imaging * No lesion greater than 5 cm in maximal dimension * Adequate clinical condition to undergo laparoscopic or robot-assisted laparoscopic liver resection or microwave ablation as treatment for colorectal cancer liver metastases * Willing and able to give informed consent
Exclusion criteria
* Radiologic (computed tomography or magnetic resonance imaging) evidence of invasion into major portal/hepatic venous branches and no extrahepatic metastases * Evidence of recurrent disease adjacent to a previous ablation or resection site * Severe renal dysfunction (creatinine clearance of \<40 mL/min) * Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local disease control at the site of intervention | 2 years | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 1, 2, 3, 5 years |
| Intrahepatic disease-free survival | 1, 2, 3, 5 years |
| Postoperative morbidity | 1 month and 3 months |
| Postoperative mortality | 1 month and 3 months |
Countries
United States
Outcome results
None listed