Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics

Liver Diseases Clinical Trial

— MWA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05471596
• Other study ID #: IRB00082683
• Secondary ID: 02-22-19E
• Status: Completed
• Start date: February 14, 2022
• Est. completion date: November 17, 2023

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Device:
• NeuWave Microwave Ablation System
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.

Locations

Country	Name	City	State
United States	Atrium Health	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Johnson & Johnson

Country where clinical trial is conducted

United States, 

References & Publications (17)

Al-Hakim RA, Abtin FG, Genshaft SJ, Kutay E, Suh RD. Defining New Metrics in Microwave Ablation of Pulmonary Tumors: Ablation Work and Ablation Resistance Score. J Vasc Interv Radiol. 2016 Sep;27(9):1380-1386. doi: 10.1016/j.jvir.2016.05.026. — View Citation

Bhardwaj N, Strickland AD, Ahmad F, El-Abassy M, Morgan B, Robertson GS, Lloyd DM. Microwave ablation for unresectable hepatic tumours: clinical results using a novel microwave probe and generator. Eur J Surg Oncol. 2010 Mar;36(3):264-8. doi: 10.1016/j.ejso.2009.10.006. Epub 2009 Oct 31. — View Citation

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. — View Citation

Deshazer G, Merck D, Hagmann M, Dupuy DE, Prakash P. Physical modeling of microwave ablation zone clinical margin variance. Med Phys. 2016 Apr;43(4):1764. doi: 10.1118/1.4942980. — View Citation

Groeschl RT, Pilgrim CH, Hanna EM, Simo KA, Swan RZ, Sindram D, Martinie JB, Iannitti DA, Bloomston M, Schmidt C, Khabiri H, Shirley LA, Martin RC, Tsai S, Turaga KK, Christians KK, Rilling WS, Gamblin TC. Microwave ablation for hepatic malignancies: a multiinstitutional analysis. Ann Surg. 2014 Jun;259(6):1195-200. doi: 10.1097/SLA.0000000000000234. — View Citation

Harari CM, Magagna M, Bedoya M, Lee FT Jr, Lubner MG, Hinshaw JL, Ziemlewicz T, Brace CL. Microwave Ablation: Comparison of Simultaneous and Sequential Activation of Multiple Antennas in Liver Model Systems. Radiology. 2016 Jan;278(1):95-103. doi: 10.1148/radiol.2015142151. Epub 2015 Jul 2. — View Citation

Hubner F, Schreiner R, Reimann C, Bazrafshan B, Kaltenbach B, Schussler M, Jakoby R, Vogl TJ. Ex vivo validation of microwave thermal ablation simulation using different flow coefficients in the porcine liver. Med Eng Phys. 2019 Apr;66:56-64. doi: 10.1016/j.medengphy.2019.02.007. Epub 2019 Feb 28. — View Citation

Iannitti DA, Martin RC, Simon CJ, Hope WW, Newcomb WL, McMasters KM, Dupuy D. Hepatic tumor ablation with clustered microwave antennae: the US Phase II trial. HPB (Oxford). 2007;9(2):120-4. doi: 10.1080/13651820701222677. — View Citation

Knavel EM, Hinshaw JL, Lubner MG, Andreano A, Warner TF, Lee FT Jr, Brace CL. High-powered gas-cooled microwave ablation: shaft cooling creates an effective stick function without altering the ablation zone. AJR Am J Roentgenol. 2012 Mar;198(3):W260-5. doi: 10.2214/AJR.11.6503. — View Citation

Laeseke PF, Lee FT Jr, van der Weide DW, Brace CL. Multiple-Antenna Microwave Ablation: Spatially Distributing Power Improves Thermal Profiles and Reduces Invasiveness. J Interv Oncol. 2009;2(2):65-72. — View Citation

Liang P, Wang Y, Yu X, Dong B. Malignant liver tumors: treatment with percutaneous microwave ablation--complications among cohort of 1136 patients. Radiology. 2009 Jun;251(3):933-40. doi: 10.1148/radiol.2513081740. Epub 2009 Mar 20. — View Citation

Liu D, Brace CL. Numerical simulation of microwave ablation incorporating tissue contraction based on thermal dose. Phys Med Biol. 2017 Mar 21;62(6):2070-2086. doi: 10.1088/1361-6560/aa5de4. Epub 2017 Feb 2. — View Citation

Livraghi T, Meloni F, Solbiati L, Zanus G; Collaborative Italian Group using AMICA system. Complications of microwave ablation for liver tumors: results of a multicenter study. Cardiovasc Intervent Radiol. 2012 Aug;35(4):868-74. doi: 10.1007/s00270-011-0241-8. Epub 2011 Aug 11. — View Citation

Martin RC, Scoggins CR, McMasters KM. Safety and efficacy of microwave ablation of hepatic tumors: a prospective review of a 5-year experience. Ann Surg Oncol. 2010 Jan;17(1):171-8. doi: 10.1245/s10434-009-0686-z. Epub 2009 Aug 26. — View Citation

Mathur AK, Ghaferi AA, Sell K, Sonnenday CJ, Englesbe MJ, Welling TH. Influence of body mass index on complications and oncologic outcomes following hepatectomy for malignancy. J Gastrointest Surg. 2010 May;14(5):849-57. doi: 10.1007/s11605-010-1163-5. Epub 2010 Feb 6. — View Citation

Poulou LS, Botsa E, Thanou I, Ziakas PD, Thanos L. Percutaneous microwave ablation vs radiofrequency ablation in the treatment of hepatocellular carcinoma. World J Hepatol. 2015 May 18;7(8):1054-63. doi: 10.4254/wjh.v7.i8.1054. — View Citation

Swan RZ, Sindram D, Martinie JB, Iannitti DA. Operative microwave ablation for hepatocellular carcinoma: complications, recurrence, and long-term outcomes. J Gastrointest Surg. 2013 Apr;17(4):719-29. doi: 10.1007/s11605-013-2164-y. Epub 2013 Feb 13. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

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