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临床试验/NCT04850430
NCT04850430尚未招募不适用

Gastric Venous Reconstruction to Reduce Gastric Venous Congestion After Total Pancreatectomy

University Hospital Heidelberg3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
3
主要终点
Incidence of gastric venous congestion

研究概览

简要总结

Total pancreatoduodenectomy (TP) is the standard surgical approach for treatment of extended pancreas tumors. If the gastric coronary vein has to be sacrificed for oncologic or for technical reasons in total pancreatectomy with splenectomy, gastric venous congestion (GVC) may result because all major venous draining routes are terminated. In the sequelae of GVC, gastric venous infarction ultimately leads to gastric perforation with abdominal sepsis. To avoid gastric venous infarction, partial or even total gastrectomy is usually performed in the event of GVC after TP. However, this significantly impacts the patient's quality of life.

Reconstruction of gastric venous outflow represents a technical approach to overcome GVC and to avoid gastric venous infarction making (partial) gastrectomy unnecessary. The current study aims to assess the role of gastric venous outflow reconstruction in GVC after TP to prevent (partial) gastrectomy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Age ≥ 18 years
  • Provide written informed consent
  • Elective total pancreatectomy for malignant or benign pancreatic lesions or chronic pancreatitis with splenectomy
  • Intraoperative ligation of coronary vein

排除标准

  • Gastric resection due to malignant infiltration
  • Non-reconstructable gastric venous drainage
  • Previous pancreas surgery

结局指标

主要结局

Incidence of gastric venous congestion

时间窗: 30 days postoperative

Gastric venous congestion after gastric venous reconstruction following total pancreatectomy

Reoperation rate

时间窗: 30 days postoperative

Reoperation rate after gastric venous reconstruction following total pancreatectomy

Morbidity rate

时间窗: 30 days postoperative

Complications rate after gastric venous reconstruction following total pancreatectomy

Incidence of gastric ischemia

时间窗: 30 days postoperative

Gastric ischemia after gastric venous reconstruction following total pancreatectomy

Postpancreatectomy gastrectomy rate

时间窗: 30 days postoperative

Rate of gastrectomy after gastric venous reconstruction following total pancreatectomy

Mortality rate

时间窗: 30 days postoperative

Mortality rate after gastric venous reconstruction following total pancreatectomy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arianeb Mehrabi, MD

Professsor, Head of the Division of Liver Surgery and Visceral Transplantation

University Hospital Heidelberg

研究点 (3)

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