Standard Preoperative Oral Immunonutrition Versus Oral Immunonutrition With Synbiotics, Sustained Omega 3 Impregnation and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion : a Prospective, Placebo-controlled, Double-blind, Randomized Clinical Trial. The SIO3D Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Calculation of the Comprehensive Complication Index (CCI)
研究概览
简要总结
The purpose of this trial is to demonstrate that synbioimmunonutrition (SI) combined with omega-3 fatty acids (O3) and Vitamin D (D) is superior to conventional 7-day preoperative immunonutrition in terms of reducing overall morbidity, in cases of duodenopancreatectomy for tumoral lesion.
详细描述
To the best knowledge of the Investigators, a comprehensive multimodal approach to reduce postoperative morbidity in duodenopancreatectomies has not yet been evaluated. In the study, the Investigators combine the main nutritional interventions currently available and already having an individual scientific basis, sequentially and simultaneously, for a potential synergistic effect.
In cases of duodenopancreatectomy for tumoral lesion, a group of patients taking only conventional immunonutrition regimen (CIR), for 7 preoperative days, will be compared with a second group where immunonutrition will be maximised by the addition of omega 3 for 1 week prior to the administration of CIR, synbiotics for 14 days pre- and post-operatively, and preoperative vitamin D supplementation for 6 days, in terms of postoperative overall morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cases of duodenopancreatectomy for tumoral lesions.
排除标准
- •Distal or total pancreatectomies, as well as procedures for chronic pancreatitis
- •Patient refusal or inability to provide informed consent
- •Use of dietary supplements containing omega 3, pre- or probiotics within 15 days prior to protocol initiation
- •Severe cardiorespiratory or renal insufficiency
- •Cirrhosis Child-Pugh B-C
- •Inability to feed by mouth
- •Intestinal obstruction
- •Unresectable tumor or metastatic disease on preoperative work-up
- •Cardiac valvular pathology
- •Short bowell syndrome
- •Haemophilia
- •Known allergy or intolerance to fish oil, fish or shellfish, milk, soy or components of the products used
- •BMI < 16kg/m2
- •Weight loss > 15% in the last 6 months
- •Little or no food in the last 10 days
- •Hypercalcemia
- •Pregnancy, breastfeeding
结局指标
主要结局
Calculation of the Comprehensive Complication Index (CCI)
时间窗: From the Day of the operation to the patient's discharge Day of the hospital, up to 90 days after surgery
This criterion takes into account all the complications of a given patient by weighting their relative importance. It varies from 0 to 100. A score of 0 means the absence of complications. A score of 100 is the death.
次要结局
- Rate of infectious or non infectious complications and rate of mortality(up to 90 days after surgery)
- Metagenomic characterization of the faecal microbiota(Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and Day-1 preoperative day)
- Blood determination of lipopolysaccharide binding protein(Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and the day of the operation)
- Research of occult-bacterial translocation in blood samples(Day+1 and Day+4 postoperative day)
研究者
Alain Pans
Head of Clinic, Department of Abdominal Surgery and Transplantation
Centre Hospitalier Universitaire de Liege