Nutritional Safety and Metabolic Benefits of Oncometabolic Surgery (Long Limb Uncut Roux-en Y Gastrojejunostomy) for Obese Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- micronutrients' deficiency (iron, folate, vitamin B12)
研究概览
简要总结
The metabolic effect of oncometabolic surgery (long limb Roux-en Y reconstruction) for early gastric cancer patients has been revealed in a few pilot studies. However, the nutritional safety has not been dealt with in previous literatures. This is a prospective pilot study for evaluating the nutritional safety and metabolic benefits of oncometabolic surgery for obese early gastric cancer patients.
详细描述
We performed long limb uncut Roux-en Y gastrojejunostomy (uRYGJ) in 20 patients with clinical T1N0 stage and preoperative body mass index (BMI) ≥ 32.5 kg/m2 or ≥ 27.5 kg/m2 with co-morbidities between September 2015 and July 2016.
The primary endpoint was the incidence of micronutrients' deficiency (iron, folate, vitamin B12) at postoperative 1 year and secondary endpoints were anemia incidence, BMI change and remission rates of co-morbidities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lesion located on distal or mid stomach Lesion confined to submucosa (cT1b) : Early gastric cancer No evidence of metastatic enlarged lymph nodes Preoperative body mass index (BMI) ≥ 32.5 kg/m2 or ≥ 27.5 kg/m2 with co-morbidities
排除标准
- •Being unable to understand the risks, benefits and compliance requirements of this trial Non- Korean speaker American society of anesthesiology (ASA) class IV or higher Other malignancy within 5 years.
研究组 & 干预措施
Oncometabolic reconstruction
Patients undergoing oncometablic surgery
干预措施: Oncometabolic reconstruction (Other)
结局指标
主要结局
micronutrients' deficiency (iron, folate, vitamin B12)
时间窗: postoperative 1-year
Iron deficiency : serum ferritin \< 20 μg/dL, Vitamin B12 deficiency : serum vitamin B12 \< 200 pg/mL,
次要结局
- Body mass index (BMI) change(postoperative 1-year)
- anemia incidence(postoperative 1-year)
- Remission rates of co-morbidities(postoperative 1-year)
研究者
Young Suk Park
Clinical Professor
Seoul National University Bundang Hospital