跳至主要内容
临床试验/NCT03124394
NCT03124394Unknown不适用

Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study

Kantonsspital Winterthur KSW1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

Evaluation of clinical outcome and economical aspects in the treatment of patients with peritoneal carcinomatosis.

详细描述

Peritoneal carcinomatosis is a dooming finding with no hope for cure and a steadily decrease in quality of life. Cytoreductive surgery with intraperitoneal chemotherapy (CRS HIPEC) offers a small but proven chance for cure. The implementation of a CRS HIPEC and PIPAC programme in a Swiss tertiary care hospital is evaluated.

When a patient is deemed non resectable, pressurized intraperitoneal aerosol chemotherapy (PIPAC) administered laparoscopically may confer effective palliation.

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

  • Men and Women >18 years
  • Tumour board decision for CRS and intraoperative chemotherapy

排除标准

  • Missing Tumour board decision for CRS and intraoperative chemotherapy
  • Pregnancy
  • Age <18 years

结局指标

主要结局

Overall Survival

时间窗: 5 years

All cause mortality since diagnosis/Intervention (in months)

Postoperative surgical complications

时间窗: 90 days

Reporting and grading of postoperative surgical complications (according to Dindo)

Disease-free survival

时间窗: 5 years

Time to recurrence measured since diagnosis/Intervention (in months)

Rehospitalisation

时间窗: 90 days

Rehospitalisation: (yes/no), time frame, cause of rehospitalisation

次要结局

  • Cost(90 days)
  • Measurement of quality of life(5 years)
  • Revenues(90 days)
  • Cost-effectiveness(90 days)
  • Cost-utility analysis(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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