跳至主要内容
临床试验/NCT04136769
NCT04136769终止不适用

Preoperative/Neoadjuvant Therapy and Vascular Debranching Followed by Resection for Locally Advanced Pancreatic Cancer

Ulrich Ronellenfitsch, MD5 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
3
试验地点
5
主要终点
Feasibility of visceral debranching

研究概览

简要总结

Pancreatic cancer continues to have a poor prognosis. Many patients are diagnosed with advanced disease. In a considerable proportion of these patients, the tumor has contact with or invades into arterial blood vessels supplying the liver or bowel. Moreover, some patients have anatomical variations or Stenosis of these vessels. All such cases require a surgical reconstruction of the blood vessels upon pancreatic cancer resection in order to prevent that the liver or bowel are not sufficiently supplied with blood anymore. Performing such arterial reconstruction in one operation along with tumor resection is associated with a relevant risk of complications or even death.

This trial evaluates if the approach of 'visceral debranching', i.e. surgical reconstruction of arterial blood vessels supplying the liver or bowel, prior to chemotherapy and finally tumor resection in patients with locally advanced pancreatic cancer, is feasible.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Feasibility of visceral debranching

时间窗: Six weeks

Proportion of patients proceeding to neoadjuvant chemotherapy (at least one dose administered within six weeks from the debranching procedure) among all patients undergoing visceral debranching

次要结局

  • Completeness of resection(Three months)
  • Perioperative morbidity (visceral debranching)(Four weeks)
  • Recurrence-free survival(Three years)
  • Overall survival(Three years)
  • Completion of therapy(Three months)
  • Perioperative morbidity (pancreatic cancer resection)(Four weeks)
  • Toxicity of chemotherapy(Three months)
  • Progression-free survival(Three years)

研究者

发起方
Ulrich Ronellenfitsch, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ulrich Ronellenfitsch, MD

Study Coordinator

Martin-Luther-Universität Halle-Wittenberg

研究点 (5)

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