跳至主要内容
临床试验/NCT00447746
NCT00447746Unknown不适用

A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial

Tata Memorial Hospital2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2007年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
2
主要终点
5 year overall survival

研究概览

简要总结

Gastric cancer remains the second most common cancer worldwide.Although the prognosis is poor for majority of patients , long term survival is achievable in patients in whom surgical resection is possible.

However the results of surgery are generally disapointing in most large series.The exception to this appears to be Japan and far east where a standardized approach to surgery is undertaken with low morbidity and mortality.The extent of surgery and particularly the development of systematic lymphadenectomy(D2)has been credited in Japan for the improved outcome in patients with gastric cancer.

Hence for comparing the difference between D1 and D2 lymphadenectomy for gastric cancer in terms of overall survival,disease free survival and loco regional recurrence and also post operative morbidity and mortality following both these procedures,this study has been undertaken.

In D1 lymphadenectomy, only those lymph nodes which are adjacent to the part of stomach being resected will be removed.In D2 lymphadenectomy other lymph nodes draining the stomach will also be removed according to internationally accepted guidelines and also include resection of greater omentum along with anterior layer of transverse mesocolon and lesser omentum upto its attachment to hepatoduodenal ligament.

Currently both these procedures are widely practised worldwide and there is no definite evidence showing the superiority of one procedure over the other.Neither is any of these procedures experimental.

We are doing this trial to see whether one of these procedures is superior to the other.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with biopsy/frozen section proven adenocarcinoma of stomach.
  • Preoperative clinical examination and imaging indicating operable disease.
  • Intraoperative exploration indicating operability i.e. no peritoneal deposits,no evidence of para aortic lymphadenopathy,no direct involvement of contiguous organs
  • Surgical plan for distal/proximal/total gastrectomy

排除标准

  • Patients with low performance score
  • Staging investigations or intraoperative exploration indicating inoperable disease
  • Patients medically unfit for major surgery
  • Patients who have been given preoperative chemotherapy/chemoradiation.
  • Patients with gastroesophageal junction tumours
  • Patients unreliable for follow up
  • Patients above the age of 70 years
  • Past history of malignancy

结局指标

主要结局

5 year overall survival

次要结局

  • : 5 year disease free survival
  • : 5 year local recurrence
  • : Postoperative morbidity and mortality rates

研究者

申办方类型
Other Gov

研究点 (2)

Loading locations...

相似试验