Evaluation of the Administration of Artificial Nutrition by Feeding Jejunostomy During Neoadjuvant Treatment on Postoperative Morbidity in the Context of Esophageal or Stomach Cancer (FREJENO)
研究概览
详细说明
Malnutrition is frequently associated with esogastric cancers at diagnosis (65-80% of cases). It has been shown that malnutrition in digestive oncology is linked to increased mortality, higher rates of postoperative complications, greater toxicity induced by chemoradiotherapy, and reduced survival. Furthermore, malnutrition present before the start of neoadjuvant treatment is likely to worsen during therapy, due to the occurrence of diarrhea, malabsorption, and dysgeusia during chemotherapy.
However, there are no recommendations regarding the use of nutritional support (type and duration) during the neoadjuvant treatment phase for esogastric cancers. Indeed, the data in the literature are quite heterogeneous regarding the duration of preoperative nutrition, ranging from a few days to several weeks, as well as the type of nutritional support to be used. No study has specifically investigated the evolution of nutritional status during this refeeding phase. As for postoperative complications, the results are mixed, although the trend suggests a reduction in postoperative complications for esophageal surgery. For gastric surgery, only one study examined surgical site infections and found a decrease in incidence when adequate nutrition was provided for more than 14 days before surgery. Nevertheless, postoperative mortality was not affected by improved nutritional status. Most of these studies are small retrospective series. The only prospective studies assessed preoperative nutrition for just 7 days before surgery, with limited sample sizes.
An educational review was published in 2012 highlighting the importance of nutritional support in malnourished patients, recommending nutritional supplementation for all patients: oral supplementation for non-malnourished patients, and jejunostomy feeding for malnourished patients.
In this context, the primary objective of this study is to evaluate the rate of postoperative complications with perioperative enteral nutrition compared to the absence of preoperative enteral nutrition.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Caroline GRONNIER, PhD, MD
- 电话号码:+335-57-62-24-77
- 邮箱:caroline.gronnier@chu-bordeaux.fr
研究联系人备份
- 姓名:Valérie AURILLAC
- 电话号码:+335-57-62-24-77
- 邮箱:valerie.aurillac@chu-bordeaux.fr
学习地点
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Pessac、法国、33600
- 招聘中
- Hôpital du Haut Lévêque
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首席研究员:
- Caroline GRONNIER, MD, PhD
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接触:
- Caroline GRONNIER
- 电话号码:+ 33 5 57 65 60 05
- 邮箱:caroline.gronnier@chu-bordeaux.fr
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
Retrospective case-control study including patients with esophageal cancer treated with neoadjuvant therapy.
The control group consists of patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.
The case group consists of patients who received enteral or parenteral nutrition during neoadjuvant treatment.
描述
Inclusion Criteria:
- Patient undergoing surgery for esophageal cancer
- Malnourished patient at the time of management
- Receiving neoadjuvant treatment
Exclusion Criteria:
- Patient not malnourished at the time of management
- Patient who did not receive neoadjuvant treatment
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Control group
patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.
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Case group
patients who received enteral or parenteral nutrition during neoadjuvant treatment.
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Patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rate of postoperative complications according to the Clavien classification
大体时间:Day 30
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Proportion of patients experiencing at least one postoperative complication, classified according to Clavien-Dindo, in malnourished patients with versus without nutritional support.
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Day 30
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合作者和调查者
调查人员
- 首席研究员:Caroline GRONNIER, MD, PhD、University Hospital, Bordeaux
出版物和有用的链接
一般刊物
- Mariette C, De Botton ML, Piessen G. Surgery in esophageal and gastric cancer patients: what is the role for nutrition support in your daily practice? Ann Surg Oncol. 2012 Jul;19(7):2128-34. doi: 10.1245/s10434-012-2225-6. Epub 2012 Feb 10.
- Deftereos I, Kiss N, Isenring E, Carter VM, Yeung JM. A systematic review of the effect of preoperative nutrition support on nutritional status and treatment outcomes in upper gastrointestinal cancer resection. Eur J Surg Oncol. 2020 Aug;46(8):1423-1434. doi: 10.1016/j.ejso.2020.04.008. Epub 2020 Apr 18.
- Deftereos I, Yeung JM, Arslan J, Carter VM, Isenring E, Kiss N, On Behalf Of The Nourish Point Prevalence Study Group. Preoperative Nutrition Intervention in Patients Undergoing Resection for Upper Gastrointestinal Cancer: Results from the Multi-Centre NOURISH Point Prevalence Study. Nutrients. 2021 Sep 15;13(9):3205. doi: 10.3390/nu13093205.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CHUBX 2025/060
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享支持信息类型
- 研究方案
- 树液
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研究美国 FDA 监管的药品
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