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临床试验/NCT00679913
NCT00679913已完成3 期

Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2005年11月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
244
试验地点
1
主要终点
Survival

研究概览

简要总结

This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.

详细描述

In Japan and in some western treatment centers, there has been a general belief that more extensive surgery may improve outcome for patients with localized, operable pancreatic adenocarcinoma. Initial retrospective reports from centers in Japan suggested that 5-year overall survival rates in patients treated with pancreaticoduodenectomy plus extended lymphadenectomy were higher than those in patients treated by pancreaticoduodenectomy with standard lymphadenectomy. Subsequent prospective randomized trials performed in Europe and the United States failed to confirm a survival benefit from extended lymphadenectomy. Although they failed to confirm a survival benefit from extended lymphadenectomy, the studies had a few pitfalls. The need for Well-designed randomised controlled study is the starting point of our study. This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •Age : 20- 85 years old
  • •No evidence of metastasis and to be possible to resect radically
  • •No history of previous radiation therapy or chemotherapy
  • •Pathological diagnosis: adenocarcinoma of pancreas
  • •Patients who agree and sign the informed consent
  • •More than 70 in Karnofsky performance scale

排除标准

  • •Past medical history of treatment for other malignant disease
  • •Recurred pancreatic cancer patients
  • •Patients with R1/R2 resection
  • •Patients who underwent neoadjuvant chemotherapy

研究组 & 干预措施

1

Active Comparator

standard pancreatoduodenectomy

干预措施: Standard pancreatoduodenectomy (Procedure)

2

Active Comparator

extended pancreatoduodenectomy

干预措施: Extended pancreatoduodenectomy (Procedure)

结局指标

主要结局

Survival

时间窗: 2 year after surgery

comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery

次要结局

  • Morbidity(within 2 years after surgery)

研究者

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

Sun-Whe Kim

Professor

Seoul National University Hospital

研究点 (1)

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