Effectiveness and Tolerance of CoSeal in the Prevention of Hepatic Adherences of Novo Post Operational Within the Framework of a Hepatic Surgery of Resection in Two Times for Hepatic Metastases: Study of Phase II/III.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- HEPATIC ADHERENCE SEVERITY
研究概览
简要总结
Study of phase II: Clinical study national, exploratory, multicentric, prospective, randomized, as a double blind man evaluating the effectiveness and the tolerance of the treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of operational adherences post.3 Study of phase III: Clinical study national, multicentric, prospective, randomized, controlled, as a double blind man comparing a group controls with a group of patients treated by a surgical gel of sealing containing polyethylene glycol in the prevention of hepatic adherences of novo post operational.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patients.
- •Hepatic Carriers of metastases.
- •Eligible with a procedure of surgical eradication in two brought closer times (time lower than 3 months).
- •Strategy validated in multidisciplinary meeting of cancerology.
- •Enlightened Assent given and signed before the intervention.
排除标准
- •Anaesthetic Counter-indications with a procedure in two times
- •Carcinose péritonéale, reached metastatic not éradicable
- •Over-sensitiveness or allergy known to polyethylene CoSeal glycol
- •Concomitant Use of another antiblocking agent
- •Immunodéprimés Patients or taking drugs immunodépresseurs with the long court like the corticosteroids,
- •Impossibility of subjecting itself to the medical monitoring imposed by the study for reasons geographical, social, psychic or medical.
- •Concomitant Participation in another clinical trial
研究组 & 干预措施
Group COSEAL
干预措施: hepatic surgery of resection (Procedure)
Reference group
干预措施: hepatic surgery of resection (Procedure)
结局指标
主要结局
HEPATIC ADHERENCE SEVERITY
时间窗: 3 years
Measure of hepatic adherence : SCORE 0: NO HEPATIC ADHERENCE SCORE 1: SHADOW ON HEPATIC ADHERENCE SCORE 2: VASCULAR OR DENSE HEPATIC ADHERENCE SCORE 3:COHESIVE HEPATIC ADHERENCE SCORE 4: DISSECTION IN ANOTHER PLAN THIS 5 SCORE WILL BE ANALYSED ON THE 8 SEGMENT AND ON PEDICLE OF LIVER
次要结局
- post operative complication(3 years)
- de novo hepatic adherence extension(3 years)
- hepatic adherence reformation(3 years)
- LIVER RELEASE VALUE(3 years)
- per operative complication(3 years)
- hospitalisation time(3 years)
- operative difficulty(3 years)
- LOSS OF BLOOD(3 years)
- CoSeal tolerance(3 years)
- liver adherence score validation(3 years)
- composite score and surgery difficulty(3 years)
- adherence composite score(3 years)