Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics

Study Overview
=================
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.

Official Title
-----------------
Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics in Hepato-Pancreato-Biliary Solid Tumors

Conditions
-----------------
Liver Diseases

Intervention / Treatment
-----------------
* Device: NeuWave Microwave Ablation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with hepatic tumors (Age >18 years or older) Treatment included microwave ablation with the Neuwave system Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NeuWave Microwave Ablation System<br>Patients who underwent a Microwave Ablation at a participating institution and a NeuWave generator was utilized. | Device: NeuWave Microwave Ablation System<br>* The NEUWAVE System supports target ablation or linear coagulation in surgical liver resection procedures. The System offers a versatile probe portfolio, multi-probe synchrony and CO2 cooling to help control the shape, size and burn pattern of your ablations.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver appearance | Investigator to describe the appearance of the liver intraoperatively | Baseline | 
| Presence of extrahepatic disease | Investigator to describe if any extrahepatic disease is present | Baseline | 
| Chronic Liver Disease Evidence | Investigator to describe if any chronic liver disease is present | Baseline | 
| Number of Lesions | Number of lesions present | Baseline | 
| Lesion location | Location (segment) of each lesion | Baseline | 
| Size of Lesion | Size of each lesion | Baseline | 
| Amount of Power used | Power (W) used to ablate each lesion | Baseline | 
| Amount of Time used | Time (min) used to ablate each lesion | Baseline | 
| Distance between lesions | The distance between liver lesions | Baseline | 
| Ablation Dimensions | 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 | day 90 | 
| Disease Recurrence Rate | Disease recurrence defined as the radiologic presence of disease present at the index location at the 4-week follow up postoperative cross-sectional imaging | week 4 | 
| Number of New lesions | New lesions noted on CT (as above) and their measurements | day 90 | 
| Radiographic liver appearance | Liver appearance on CT | day 90 | 
| Radiographic extrahepatic disease | Presence of extrahepatic disease on CT | day 90 | 
| Tumor measurement | Index tumor diameter and volume | Baseline | 
| Ablation Time | The time at which ablation occurred | Baseline | 
| Ablation Energy output | Energy output from ablation | Baseline | 
| Ablation Margins | Ablation margins | day 90 | 
| Operative Time Amount | Time from first incision until final skin closure | Baseline | 
| Length of Stay | Time from hospital admission until hospital discharge | up to 90 days | 
| Readmission Rates | Percentage of patients who were readmitted to the hospital after MWA | day 90 | 
| 30 day complication rate | Percentage of patients who experienced a complication 30 following MWA | day 30 | 
| 90 day complication rate | Percentage of patients who experienced a complication 90 following MWA | day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Cancer, Liver Lesion, Microwave Ablation, NeuWave Surgical, Hepatobiliarypancreato Surgery, Hepato-Pancreato-Biliary (HPB) Surgery