Randomized Trial of Argon Plasma Coagulation Versus Argon Plasma Coagulation and Hemospray in the Therapy of Radiation Proctitis
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- cessation of rectal bleeding
研究概览
简要总结
Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and Hemospray in the therapy of bleeding from Radiation Proctitis
详细描述
20 patients with Radiation Proctitis will be randomized to receive either Argon Plasma Coagulation therapy alone or therapy with APC followed by Hemospray administration ;the treatment in each arm is administered during a sigmoidoscopic examination
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bleeding from radiation proctitis
排除标准
- •pregnancy bleeding diathesis
研究组 & 干预措施
argon plasma coagulation
argon plasma coagulation of radiation proctitis
干预措施: Hemospray (Other)
argon plasma coagulator and hemospray
treatment of radiation proctitis with argon plasma coagulator followed by application of hemospray
干预措施: Hemospray (Other)
结局指标
主要结局
cessation of rectal bleeding
时间窗: 12 months
treatment of one group of patients with Radiation Proctitis with Argon Plasma Coagulator ( APC) and a second group will be treated with APC and Hemospray
次要结局
- number of treatments required to achieve cessation of rectal bleeding(12 months)
研究者
Alan Weiss
Principal Investgator
British Columbia Cancer Agency