跳至主要内容
临床试验/NCT01278368
NCT01278368已完成不适用

PREOPERATIVE CHEMOTHERAPY DOES NOT ADVERSELY AFFECT SHORT-TERM OUTCOME AFTER PANCREATIC RESECTION.

Università Vita-Salute San Raffaele2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2003年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Postoperative morbidity rate

研究概览

简要总结

No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.

详细描述

Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Diagnosis of pancreatic cancer
  • Preoperative chemotherapy
  • Pancreatic resection

排除标准

  • Metastatic disease
  • ASA score 4

研究组 & 干预措施

Preoperative chemotherapy (PCHT)

Active Comparator

Patients who underwent pancreatic resection after PCHT.

干预措施: Pancreatic resection after preoperative chemotherapy (Procedure)

Control

Active Comparator

Patient who underwent pancreatic resection without preoperative therapy

干预措施: Pancreatic resection (Procedure)

结局指标

主要结局

Postoperative morbidity rate

时间窗: Postoperative. From 0 to 30 days after discharge

次要结局

  • Postoperative mortality(Postoperative. From 0 to 30 days after discharge)
  • Length of hospital stay (LOS)(Postoperative. From 0 to 30 days after discharge)

研究者

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

Marco Braga

Associate Professor of Surgery

Università Vita-Salute San Raffaele

研究点 (2)

Loading locations...

相似试验