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临床试验/NCT07014800
NCT07014800已完成不适用

Multi-frequency MR Elastography Based Tomoelastography: Additional New Imaging Tool for Postoperative Pancreatic Fistula Risk Stratification

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2021年11月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
157
试验地点
1
主要终点
Postoperative pancreatic fistula

研究概览

简要总结

Postoperative pancreatic fistula (POPF) is a prevalent and severe complication of pancreaticoenteric anastomosis; however, its accurate preoperative prediction is challenging. Multi-frequency MR elastography-based tomoelastography can quantify pancreatic mechanical properties (stiffness and fluidity), thus further improving the predictive performance of conventional MRI for postoperative pancreatic fistulas.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Participants diagnosed with postoperative pancreatic fistula who underwent both preoperative multi-frequency MRE and pancreaticoenteric anastomosis were included in the study.

排除标准

  • without appropriate image quality; without available pathological data

结局指标

主要结局

Postoperative pancreatic fistula

时间窗: The participants were routinely examined on days 1, 3, 5, and 7 after surgery to determine fluid volumes and serum amylase levels.

Any measurable drainage of amylase levels above three times the upper limit of the normal amylase level on or after the third postoperative day was considered the essential threshold of diagnosing postoperative pancreatic fistula.

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Siya Shi

clinical doctor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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