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临床试验/NCT05434520
NCT05434520已完成不适用

Relieving the Bile Ducts Prior to Pancreatoduodenectomy

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 722 人开始时间: 2021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
722
试验地点
1
主要终点
30-day Mortality

研究概览

简要总结

The aim of this study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.

A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021. Patients who had preoperative bile duct drainage were compared to patients without intervention. Type of interventions, complications and outcome after surgery were compared using univariate and multivariate analysis.

详细描述

Obstructive jaundice is a common problem in pancreatic and periampullary tumors, but preoperative biliary drainage in patients with hyperbilirubinemia is still controversial. The aim of this retrospective cohort study was to assess the risk and complications after preoperative drainage of biliary obstruction in patients who underwent pancreatoduodenectomy.

A retrospective cohort study of all patients who underwent pancreatoduodenectomy from January 1st, 2015 to September 30th, 2021.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • All patients who had undergone pancreatoduodenectomy

排除标准

  • 未提供

结局指标

主要结局

30-day Mortality

时间窗: up to 30 days

30-day mortality rate post-pancreatoduodenectomy

90-day Mortality

时间窗: up to 90 days

90-day mortality rate post-pancreatoduodenectomy

Length of Hospital Stay

时间窗: Days from admission until discharge, up to 390 days, median time 13 days

Accumulated length of hospital stay from the admission day prior to pancreatoduodenectomy, till the day of discharge.

30-day Readmission

时间窗: up to 30-days from hospital discharge

Prevalence of readmission within 30-days after discharge following pancreatoduodenectomy.

Post-operative complication score (Clavien-Dindo)

时间窗: During hospital admission, median time 13 days, up to 390 days.

The prevalence of complications graded according to Clavien-Dindo score after pancreatoduodenectomy. Clavien-Dindo 0 is no complications, Clavien-Dindo 5 means complications resulting in mortality.

次要结局

  • Histological Specimen(Obtained within 21 days after resection)
  • Complications following preoperative bile duct drainage(up to 7 days after bile duct drainage)
  • Time from Bile Duct Drainage to Pancreatoduodenectomy(Days from bile duct decompression to pancreatoduodenectomy, median time 32 days, up to 534 days)

研究者

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

Waqas Farooqui

Principal Investigator

Rigshospitalet, Denmark

研究点 (1)

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