跳至主要内容
临床试验/NCT00757640
NCT00757640已完成不适用

The CHOLEGAS Study: Multicentric Randomized, Double-blinded, Controlled Trial of Gastrectomy Plus Prophylactic Cholecystectomy Versus Gastrectomy Only, in Adults Submitted to Gastric Cancer Surgery With Curative Intent.

Italian Research Group for Gastric Cancer2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2008年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Reduced biliary complications

研究概览

简要总结

The patients will be divided into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group will be submitted to standard gastric surgery only.

详细描述

The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

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

  • Patients undergoing standard gastric surgery for cancer

排除标准

  • gallbladder disease

结局指标

主要结局

Reduced biliary complications

时间窗: 5 years

次要结局

  • Improved quality of life(5 years)

研究者

发起方
Italian Research Group for Gastric Cancer
申办方类型
Network
责任方
Principal Investigator
主要研究者

Bencini Lapo

Dr, PhD

Italian Research Group for Gastric Cancer

研究点 (2)

Loading locations...

相似试验