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临床试验/NCT01278381
NCT01278381已完成不适用

A PROGNOSTIC SCORE TO PREDICT MAJOR COMPLICATIONS AFTER PANCREATICODUODENECTOMY.

Università Vita-Salute San Raffaele1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2002年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
700
试验地点
1
主要终点
Major Complication rate

研究概览

简要总结

Pancreaticoduodenectomy (PD) still carries a high rate of severe postoperative complications. No score is currently available to help identify the patient's surgical risk. The purpose of this study was to develop and validate a prognostic score to predict major postoperative complications after PD.

详细描述

The investigators prospectively collected in an electronic database preoperative, intraoperative and outcome data of 700 patients undergoing PD in our Institution from 2002 to 2010. The investigators used a multivariate logistic regression analysis to create a new score to predict severe complications defined as Clavien-Dindo classification III, IV and V. The score was developed using a random two-thirds of the population (469 patients), and was then validated and calibrated in the remaining third of the patients (231).

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing pancreaticoduodenectomy in our Institution

排除标准

  • Metastatic disease
  • Patient not suitable for surgery

结局指标

主要结局

Major Complication rate

时间窗: Postoperative. Until 30 days after discharge

Clavien-Dindo grade III to V complications considered as major

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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