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临床试验/NCT03791450
NCT03791450已完成不适用

A Multicenter Big⁃Sample Retrospective Study of Pancreaticoduodenectomy

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 10,085 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10,085
试验地点
1
主要终点
Incidence of Postoperative Pancreatic Fistula(POPF)

研究概览

简要总结

The investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

详细描述

For patients with malignant or benign disease of the pancreatic head and periampullary region, pancreaticoduodenectomy is the only potential approach to radical cure. However, pancreaticoduodenectomy is consider as one of the most complex operations associated with a high rate of postoperative complications such as pancreatic fistula, delayed gastric emptying, hemorrhage, abscess, and sepsis. These complications increase the costs associated with pancreaticoduodenectomy. Numerous interventions and techniques have been introduced to decrease the morbidity. But there is little evidence for the superiority of one anastomotic technique over the others. Therefore, investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.

排除标准

  • 未提供

结局指标

主要结局

Incidence of Postoperative Pancreatic Fistula(POPF)

时间窗: Within 30 days after surgery

The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria.

次要结局

  • Mortality(Within 30 days after surgery)
  • Duration of operation(Intraoperative)
  • Length of hospital stay after surgery(From first day after surgery to release from hospital (anticipate 5 days minimally))
  • Morbidity(Within 90 days after surgery)
  • Hospital costs(From first day after surgery to release from hospital (anticipate 5 days minimally))

研究者

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

Chen Xiaoping

Principal Investigator

Tongji Hospital

研究点 (1)

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