跳至主要内容
临床试验/NCT05471596
NCT05471596已完成不适用

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

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with hepatic tumors (Age >18 years or older)
  • Treatment included microwave ablation with the Neuwave system

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 30 day complication rate(day 30)
  • 90 day complication rate(day 90)
  • Radiographic liver appearance(day 90)
  • Operative Time Amount(Baseline)
  • Presence of extrahepatic disease(Baseline)
  • Size of Lesion(Baseline)
  • Readmission Rates(day 90)
  • Number of Lesions(Baseline)
  • Ablation Energy output(Baseline)
  • Chronic Liver Disease Evidence(Baseline)
  • Distance between lesions(Baseline)
  • Number of New lesions(day 90)
  • Disease Recurrence Rate(week 4)
  • Ablation Margins(day 90)
  • Radiographic extrahepatic disease(day 90)
  • Liver appearance(Baseline)
  • Lesion location(Baseline)
  • Amount of Power used(Baseline)
  • Amount of Time used(Baseline)
  • Ablation Dimensions(day 90)
  • Tumor measurement(Baseline)
  • Ablation Time(Baseline)
  • Length of Stay(up to 90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验