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临床试验/NCT02376231
NCT02376231已完成不适用

A Pilot Single Blinded Randomized Controlled Trial to Evaluate the Utility and Efficacy of Neutral Argon Plasma as a New Technology in Achieving Complete Cytoreduction of Advanced Epithelial Ovarian Carcinoma- Initial Feasibility Study

Dr Thumuluru Kavitha Madhuri2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Ability to achieve complete cytoreduction (nil macroscopic residual disease) either with current standard surgery or using PJ.

研究概览

简要总结

Surgery for ovarian cancer involves a big cut on your tummy (abdomen) followed by removal of pelvic organs (womb, tubes and ovaries), abdominal organs (fat tissue {omentum}, appendix) and any other tissues involved with cancer. Several studies worldwide have reported that women survive longer and enjoy a longer disease free interval before their disease returns if all visible disease is removed at the time of their surgery. Achieving this is not easy and often there is widespread disease and the surgeons are unable to remove every tumour nodule present as it is attached to the surface of the bowel, diaphragm and other important Extensive surgery with prolonged operating is associated with higher risks. Plasma energy is commonly referred to as the 4th state of matter after solid, liquid and gas. When a gas is heated, it partially or wholly ionizes resulting in high energy particles like ions, electrons and atoms referred to as 'plasma'. PlasmaJet® (PJ) is a new device which uses fine jet of neutral argon plasma from the handpiece that has been shown to have the ability to vaporise nodules close to sensitive organs like the bowel. It may offer the potential to treat the tumour nodules close to sensitive areas like the bowel. There have been no studies exploring its role in vaporising tumour nodules and its impact on survival. The PJ may be used by the surgeon to seal bleeding tissues (coagulate) or to burn away thin layers of tissue (ablate) by vaporization. It is licensed for use to achieve effects of coagulation and ablation. It is similar to conventional surgical devices that are routinely used (called diathermy) to achieve these effects. The PJ however is slightly different in that it may also be used on tissue to vaporise tumour nodules in women with ovarian cancer during surgery though the full extent of this role remains unclear.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Imaging+/- Clinical +/- laparoscopic e/o pelvic mass and metastatic disease (FIGO III/IV disease) at presentation.
  • Confirmation of malignancy on histological/cytological criteria.
  • All women aged 18 or over with newly diagnosed FIGO stage III to Stage IV EOC undergoing surgical treatment.
  • All women fit to undergo treatment.
  • No synchronous malignancy likely to interfere with comparisons.
  • Written and informed patient consent

排除标准

  • Patient choice
  • Patient unfit for any treatment modality
  • Patients who are medically unfit for surgery and would only be suitable for chemotherapy.
  • WITHDRAWAL CRITERIA
  • Unforeseen complications in the individual patient will be recorded and then analysed.
  • Life threatening situation to the patient, due to any other unrelated complication.
  • Patients are free to withdraw from the study at any time with no impact on their care whatsoever.

研究组 & 干预措施

Standard Surgery without trial (PJ) device

No Intervention

Standard debulking surgery for EOC without interventional device

Surgery with trial (PJ) device

Active Comparator

Debulking surgery for EOC with interventional trial device (PJ)

干预措施: Surgery for EOC with trial (PJ) device (PlasmaJet) (Device)

结局指标

主要结局

Ability to achieve complete cytoreduction (nil macroscopic residual disease) either with current standard surgery or using PJ.

时间窗: At surgery

次要结局

  • Bowel resection rate(6months)
  • Disease Free Survival(3years)
  • Post-operative morbidity(30 days)
  • Per-operative morbidity(30 days)
  • Stoma formation rate(6 months)
  • Cost-effectiveness(3years)
  • Overall Survival(5 years)
  • Quality of Life(3 years)

研究者

发起方
Dr Thumuluru Kavitha Madhuri
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Thumuluru Kavitha Madhuri

Clinical Research Fellow

Royal Surrey County Hospital NHS Foundation Trust

研究点 (2)

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