跳至主要内容
临床试验/NCT03699917
NCT03699917已完成不适用

The Impact of Intraoperative Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年1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
64
试验地点
1
主要终点
Postoperative complications (Pancreatic leak and delayed gastric emptying)

研究概览

简要总结

Optimal fluid balance is critical to minimize anastomotic edema in patients undergoing pancreaticoduodenectomy. This study examined the effects of decreased fluid administration on rates of postoperative pancreatic leak and delayed gastric emptying.

详细描述

Retrospective study of 10564 patients undergoing pancreaticoduodenectomy at a single institution from January, 2015 through July, 2016. Stroke volume variation (SVV) was tracked and titrated during the procedure.

All patients were seen preoperatively in the department clinic setting, and indications for pancreaticoduodenectomy were for pancreatic adenocarcinoma, neuroendocrine tumors, chronic pancreatitis, non-adeno malignancy, and other benign. benign and malignant disease.

Patients were excluded if they had any of the following during surgery: venous resection and reconstructive involving the portal venous system; estimated blood loss exceeding two liters; high dose steroid administration; use of irreversible electroporation for margin enhancement; lack of SVV equipment or inconsistent SVV recordings; use of the robotic surgical system.

Primary outcomes measures were recorded for each patient were: pancreatic leak and delayed gastric emptying. Pancreatic leak was defined according to the international study group for pancreatic fistulas: "an external fistula with a drain output of any measurable volume after postoperative day three with an amylase level greater than three times the upper limit of the normal serum value." Delayed gastric emptying was defined clinically as persistent postoperative emesis requiring nasogastric tube placement, prokinetic agents, or hospital readmission for endoscopic gastrostomy placement.

A comparative analysis of postoperative complications was performed between patients with a median SVV < 12 during the extirpative and reconstructive phases of the procedure compared with patients with an SVV > 12. The investigators chose an SVV value of greater than 12 to represent a "dry" state because previous studies have shown that this value represents decreased fluid administration.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • pancreatic adenocarcinoma, neuroendocrine tumors, chronic pancreatitis, non-adeno malignancy, and other benign lesion

排除标准

  • venous resection and reconstructive involving the portal venous system
  • estimated blood loss exceeding two liters
  • high dose steroid administration
  • use of irreversible electroporation for margin enhancement
  • lack of SVV equipment or inconsistent SVV recordings
  • use of the robotic surgical system

结局指标

主要结局

Postoperative complications (Pancreatic leak and delayed gastric emptying)

时间窗: 30 days postoperatively

Number of patients with postoperative pancreatic leak and postoperative delayed gastric emptying. Stroke volume is calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验