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临床试验/NCT05687825
NCT05687825已完成不适用

Operative Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Multicenter Cohort Study

South Valley University1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2017年8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
107
试验地点
1
主要终点
clinically relevant post operative pancreatic fistula

研究概览

简要总结

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

详细描述

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

研究设计

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

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
  • American Society of Anesthesiologists (ASA) scores I & II.
  • Patients aged > 20 years.
  • Agreement to complete the study.

排除标准

  • Patients with benign disease, trauma, and receive neoadjuvant therapy.
  • double primary cancers.

结局指标

主要结局

clinically relevant post operative pancreatic fistula

时间窗: 10 days

A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day

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

Mohammed Ahmed Omar, MD

Associate professor of surgery

South Valley University

研究点 (1)

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