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Resection Versus Microwave Ablation for Resectable Colorectal Cancer Liver Metastases

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ClinicalTrials.gov Identifier: NCT02866344
Recruitment Status : Terminated (Lack of funding)
First Posted : August 15, 2016
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Atrium Health

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Neoplasm Metastasis Hepatic Neoplasms Procedure: Microwave ablation Procedure: Hepatic resection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison of Resection and Microwave Ablation for Resectable Colorectal Cancer Liver Metastases
Actual Study Start Date : August 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Active Comparator: 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.
Procedure: Hepatic resection
Laparoscopic or robot-assisted laparoscopic surgical resection of cancerous lesions.
Other Name: Surgery




Primary Outcome Measures :
  1. Local disease control at the site of intervention [ Time Frame: 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 Outcome Measures :
  1. Overall survival [ Time Frame: 1, 2, 3, 5 years ]
  2. Intrahepatic disease-free survival [ Time Frame: 1, 2, 3, 5 years ]
  3. Postoperative morbidity [ Time Frame: 1 month and 3 months ]
  4. Postoperative mortality [ Time Frame: 1 month and 3 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866344


Locations
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United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Dionisios Vrochides, MD PhD Carolinas Medical Center

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Responsible Party: Atrium Health
ClinicalTrials.gov Identifier: NCT02866344     History of Changes
Other Study ID Numbers: 06-16-02A
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atrium Health:
Microwave ablation
Ablation techniques
Operative surgical procedures
Hepatic resection
Surgery
Outcomes assessment

Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases