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临床试验/NCT01528059
NCT01528059Unknown2 期

A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer Comorbid With Type 2 Diabetes

feng Zheng1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2012年2月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
110
试验地点
1
主要终点
Glycemic control

研究概览

简要总结

Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be varied by different gastric-small intestine reconstruction used in the procedure. There are reports that Roux en Y reconstruction may give a better result. The purpose of this study is to compare Roux en Y and Billroth II reconstruction in patients with gastric cancer comorbid with type 2 diabetes.

详细描述

Type 2 diabetes may cause severe complications such as nephropathy and retinopathy. Additionally, it is associated with increased risk for cardiovascular events and diseases. Surgical intervention with gastric bypass has been shown to attenuate glycemic levels in obese patient comorbid with type 2 diabetes. However, since gastric bypass is not a standard procedure, surgical protocol including stomach and small intestine reconstruction may be varied. The investigators and others have found that stomach and small intestine reconstruction may affect the efficacy of diabetic treatment. In this study, the investigators will compare the efficacy of Billroth II and Roux en Y reconstruction on glycemic control in stomach cancer patients with type 2 diabetes. Both Billroth II and Roux en Y are used in stomach-small intestine reconstruction after subtotal gastrectomy. No differences in postoperative outcomes and quality of life have been reported in Billroth II and Roux en Y reconstruction.

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
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Type 2 diabetes
  • Diagnosed with gastric cancer

排除标准

  • Type 1 diabetes
  • Unresectable cancers

结局指标

主要结局

Glycemic control

时间窗: 1 year after surgery

1. Fasting and postprandial glycemic levels, HbA1C 2. Number of anti-diabetic drugs 3. Dosage of anti-diabetic drugs

次要结局

  • Nutritional status assessment(1 year after surgery)

研究者

发起方
feng Zheng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

feng Zheng

MD

Xiamen University

研究点 (1)

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