Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 02-22-19E | Other Identifier | Atrium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuWave Microwave Ablation System | Patients who underwent a Microwave Ablation at a participating institution and a NeuWave generator was utilized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuWave Microwave Ablation System | Device | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adults (Age >18 years old) with hepatic lesion(s) treated by microwave ablation
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David A Iannitti, MD | Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health | Charlotte | North Carolina | 28203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20140536 | Background | 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. | |
| 24096760 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 23404173 | Background | 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. |
| 19880269 | Background | 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. |
| 18333126 | Background | 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. |
| 19707829 | Background | 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. |
| 19304921 | Background | 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. |
| 21833809 | Background | 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. |
| 21857888 | Background | 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. |
| 26133361 | Background | 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. |
| 22358023 | Background | 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. |
| 26052394 | Background | 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. |
| 27566426 | Background | 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. |
| 27036574 | Background | 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. |
| 28151729 | Background | 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. |
| 30826254 | Background | 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. |
| 19638912 | Background | 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. |