Clinical trial NCT05471596: Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics
Official title: Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics in Hepato-Pancreato-Biliary Solid Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Keywords: Liver Cancer
Liver Lesion
Microwave Ablation
NeuWave Surgical
Hepatobiliarypancreato Surgery
Hepato-Pancreato-Biliary (HPB) Surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2022-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (Age \>18 years old) with hepatic lesion(s) treated by microwave ablation

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.

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

Primary outcomes:
measure: 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
timeFrame: Year 2
Secondary outcomes:
measure: Liver appearance
timeFrame: Baseline
measure: Presence of extrahepatic disease
timeFrame: Baseline
measure: Chronic Liver Disease Evidence
timeFrame: Baseline
measure: Number of Lesions
timeFrame: Baseline
measure: Lesion location
timeFrame: Baseline
measure: Size of Lesion
timeFrame: Baseline
measure: Amount of Power used
timeFrame: Baseline
measure: Amount of Time used
timeFrame: Baseline
measure: Distance between lesions
timeFrame: Baseline
measure: Ablation Dimensions
timeFrame: day 90
measure: Disease Recurrence Rate
timeFrame: week 4
measure: Number of New lesions
timeFrame: day 90
measure: Radiographic liver appearance
timeFrame: day 90
measure: Radiographic extrahepatic disease
timeFrame: day 90
measure: Tumor measurement
timeFrame: Baseline
measure: Ablation Time
timeFrame: Baseline
measure: Ablation Energy output
timeFrame: Baseline
measure: Ablation Margins
timeFrame: day 90
measure: Operative Time Amount
timeFrame: Baseline
measure: Length of Stay
timeFrame: up to 90 days
measure: Readmission Rates
timeFrame: day 90
measure: 30 day complication rate
timeFrame: day 30
measure: 90 day complication rate
timeFrame: day 90
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
Study officials:
affiliation: Physician
name: David A Iannitti, MD
role: PRINCIPAL_INVESTIGATOR
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