Back to resultsResection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases
Primary Purpose
Colorectal Neoplasms, Neoplasm Metastasis, Hepatic Neoplasms
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microwave ablation
Hepatic resection
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Microwave ablation, Ablation techniques, Operative surgical procedures, Hepatic resection, Surgery, Outcomes assessment
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
Sites / Locations
- Carolinas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Microwave ablation
Hepatic resection
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall survival
Intrahepatic disease-free survival
Postoperative morbidity
Postoperative mortality
Full Information
NCT ID
NCT02866344
First Posted
August 10, 2016
Last Updated
April 20, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02866344
Brief Title
Resection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases
Official Title
Prospective Randomized Comparison of Resection and Microwave Ablation for Resectable Colorectal Cancer Liver Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
August 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Neoplasm Metastasis, Hepatic Neoplasms
Keywords
Microwave ablation, Ablation techniques, Operative surgical procedures, Hepatic resection, Surgery, Outcomes assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microwave ablation
Arm Type
Experimental
Arm Description
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.
Arm Title
Hepatic resection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Microwave ablation
Intervention Description
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
Intervention Name(s)
Hepatic resection
Other Intervention Name(s)
Surgery
Intervention Description
Laparoscopic or robot-assisted laparoscopic surgical resection of cancerous lesions.
Primary Outcome Measure Information:
Title
Local disease control at the site of intervention
Description
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
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
1, 2, 3, 5 years
Title
Intrahepatic disease-free survival
Time Frame
1, 2, 3, 5 years
Title
Postoperative morbidity
Time Frame
1 month and 3 months
Title
Postoperative mortality
Time Frame
1 month and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dionisios Vrochides, MD PhD
Organizational Affiliation
Carolinas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Resection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases
We'll reach out to this number within 24 hrs