Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics
- Conditions
- Liver Diseases
- Interventions
- Device: NeuWave Microwave Ablation System
- Registration Number
- NCT05471596
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
To prospectively collect and evaluate pre-operative, intra-operative, and post-operative variables for all patients undergoing surgical microwave ablation. All patients who have a surgical microwave ablation with the Neuwave system will be added to the database after their treatment and procedures have been completed.
- Detailed Description
To prospectively collect and evaluate pre-operative, intra-operative, and post-operative variables for all patients undergoing surgical microwave ablation. All patients who have a surgical microwave ablation with the Neuwave system will be added to the database after their treatment and procedures have been completed. All data points will be collected from the electronic medical records (EMR) (office visit notes, operative notes, follow-up visits, CT scans, etc.). The collected data points will be utilized to study outcomes such as local/regional reoccurrences and distant occurrences related to hepatic tumor(s), whether there was complete destruction, residual disease/incomplete destruction, or recurrence at the ablation site. Overall-complications, length of stay, readmission rates, and any additional outcomes data that is relevant to MWA and improving surgical outcomes will also be collected.
There are various Microwave Ablation (MWA) systems available that are utilized at the study locations to treat hepatic tumors. For this study, the focus is on subjects treated with the Certus 140TM system from NeuWave Medical®. Certus 140TM microwave generator possesses a 2.45 gigahertz (GHz) operating frequency and can power up to 140 watts. It can deliver microwave energy through three distinct channels simultaneously through a single system and uses three distinct antenna types (LK, SR, PR). It also contains a CO2-based cooling system that helps limit the temperature of the handle and cable. It is compatible with a variety of probes (LK, SR and PR antenna) and offers two modes, Ablation mode and Surgical mode. The Ablation mode is used for ablating a substantial target for several minutes until the object of the ablation is necrotic. Surgical Mode is used to ablate or coagulate a target for shorter periods of time while frequently moving the probe in a technique known as "planar coagulation."
Current data and manufacturer guidelines for recommended ablation energy outputs for microwave ablation systems are obtained via ex vivo and animal models with tissues that exhibit different properties of energy transference than in vivo human tissues, particularly, human hepatic solid tumors. The objective is to prospectively assess the thermodynamics of microwave ablation energy in this context, specifically through the creation of power/time curves to predict future ablation volumes through single applications of MWA energy per lesion.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Adults with hepatic tumors (Age >18 years or older)
- Treatment included microwave ablation with the Neuwave system
- Age <18
- Benign Tumors
- Patients whose initial treatment plan did not include MWA, although they later received one (rescue MWA)
- Multiple tumors with distances or geometric relations rendering volumetrics incalculable or unduly confounded
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NeuWave Microwave Ablation System NeuWave Microwave Ablation System Patients who underwent a Microwave Ablation at a participating institution and a NeuWave generator was utilized.
- Primary Outcome Measures
Name Time Method Prospective Power/Time Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics in Hepato-Pancreato-Biliary Sold Tumors Utilizing a Single Generator at a Single Surgical Center Year 2 The primary objective is to prospectively assess the thermodynamics of microwave ablation energy in this context, specifically through the creation of power/time curves to predict future ablation volumes through single applications of MWA energy per lesion.
- Secondary Outcome Measures
Name Time Method Number of New lesions day 90 New lesions noted on CT (as above) and their measurements
Size of Lesion Baseline Size of each lesion
Distance between lesions Baseline The distance between liver lesions
30 day complication rate day 30 Percentage of patients who experienced a complication 30 following MWA
90 day complication rate day 90 Percentage of patients who experienced a complication 90 following MWA
Operative Time Amount Baseline Time from first incision until final skin closure
Radiographic liver appearance day 90 Liver appearance on CT
Presence of extrahepatic disease Baseline Investigator to describe if any extrahepatic disease is present
Readmission Rates day 90 Percentage of patients who were readmitted to the hospital after MWA
Number of Lesions Baseline Number of lesions present
Ablation Energy output Baseline Energy output from ablation
Chronic Liver Disease Evidence Baseline Investigator to describe if any chronic liver disease is present
Disease Recurrence Rate week 4 Disease recurrence defined as the radiologic presence of disease present at the index location at the 4-week follow up postoperative cross-sectional imaging
Ablation Margins day 90 Ablation margins
Liver appearance Baseline Investigator to describe the appearance of the liver intraoperatively
Lesion location Baseline Location (segment) of each lesion
Amount of Power used Baseline Power (W) used to ablate each lesion
Amount of Time used Baseline Time (min) used to ablate each lesion
Ablation Dimensions day 90 Ablation dimensions as assessed by post-operative cross-sectional imaging using the x-axis along the length of the antenna tract and y-axis perpendicular to the antenna tract
Radiographic extrahepatic disease day 90 Presence of extrahepatic disease on CT
Tumor measurement Baseline Index tumor diameter and volume
Ablation Time Baseline The time at which ablation occurred
Length of Stay up to 90 days Time from hospital admission until hospital discharge
Trial Locations
- Locations (1)
Atrium Health
🇺🇸Charlotte, North Carolina, United States