Resection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases

NCT02866344 | Terminated DMC

• 2 other identifiers: IRB0008318106-16-02A
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

Microwave ablation; Ablation techniques; Operative surgical procedures; Hepatic resection; Surgery; Outcomes assessment

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (4)

• 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

Study Arms (2)

Microwave ablation

EXPERIMENTAL

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.

Procedure: Microwave ablation

Hepatic resection

ACTIVE COMPARATOR

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.

Procedure: Hepatic resection

Interventions

Microwave ablation 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.

Microwave ablation

Hepatic resection PROCEDURE

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

Also known as: Surgery

Hepatic resection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases

Study Officials

• Dionisios Vrochides, MD PhD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 15, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 26, 2022

Record last verified: 2021-01

Locations

US (1)