Resection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases

NCT ID: NCT02866344

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-02-28

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.

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Hepatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Microwave ablation

Patients will be given general anesthesia. A laparoscopic trocar and additional ports will be placed under direct visualization and pneumoperitoneum will be established. Once the operating surgeon determines that the lesions as evaluated on intraoperative ultrasound remain amenable to MWA, ablations will be performed with a 2.45-gigahertz (GHz) generator with a 1.8-mm-diameter transcutaneous antenna (Acculis pMTA Accu2i; AngioDynamics Inc., Denmead, Hampshire, UK). Additional ablations will be performed sequentially. Laparoscopic core needle biopsy of lesions will be performed and submitted for permanent pathologic sectioning per current treatment standards. At the conclusion of the ablation, a collapsed titanium clip will be inserted into the microwave antenna tract as a radiographic fiducial marker. Hemostasis of the ablation track will be ensured using a combination of microwave energy, monopolar electrocautery, and/or topical hemostatics.

Group Type: EXPERIMENTAL

Microwave ablation

Intervention Type: PROCEDURE

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.

Hepatic resection

General anesthesia will be induced. A laparoscopic trocar and additional ports will be placed under direct visualization and pneumoperitoneum will be established. The liver will be evaluated with intraoperative ultrasound (BK Medical A/S, Herlev, Denmark). Laparoscopic core needle biopsy of lesions will be performed. Partial hepatectomy may be carried out with parenchymal precoagulation with radiofrequency electrosurgical devices such as the LigaSure™ (Covidien, Medtronic; Minneapolis, MN), Harmonic® (Ethicon Endosurgery; Cincinnati, OH), or saline-coupled radiofrequency ablation device (Aquamantys™; Covidien/Medtronic; Minneapolis, MN); hepatic parenchymal transection can be performed as above or with the use of stapling devices to ligate and divide parenchyma. Hepatic vascular inflow occlusion will be performed at the surgeon's discretion. A topical hemostatic may be used along the transected hepatic parenchyma. Resected specimens will be preserved in formalin for pathology.

Group Type: ACTIVE_COMPARATOR

Hepatic resection

Intervention Type: PROCEDURE

Laparoscopic or robot-assisted laparoscopic surgical resection of cancerous lesions.

Interventions

Microwave 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.

Intervention Type: PROCEDURE

Hepatic resection

Laparoscopic or robot-assisted laparoscopic surgical resection of cancerous lesions.

Intervention Type: PROCEDURE

Other Intervention Names

Surgery

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dionisios Vrochides, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Carolinas Medical Center

Locations

Carolinas Medical Center

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

06-16-02A

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00083181

Identifier Type: -

Identifier Source: org_study_id