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临床试验/NCT03167814
NCT03167814招募中不适用

Prevention of Chyle-leak After Major Pancreatic Surgery

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
96
试验地点
1
主要终点
Chyle-leakage reduced from operating area after surgery

研究概览

简要总结

Chyle is lymphatic fluid present in the wall of the intestine. It flows trough lymphatic vessels to cisterna chyli and to venous circulation carrying lymphatic fluid, long-chain triglyceride fatty acids and proteins, fatty soluble vitamins and electrolytes. Lymphatic vessels are at risk of damage in pancreatic surgery and especially when there is vein/artery resection and reconstruction at the same time. Chyle leak can be seen in post-operative patients when there is milky substance coming out of the surgical drains and drain fluids triglyceride level is high (>1,5 mmol/l). Patients with chyle leak are at risk of dehydration, malnutrition, sepsis and prolonged stay at the hospital. Usually treatment of chyle leak is with drains and no-fat diet up to 14 days after surgery. Sometimes combined with somatostatine-analogue-treatment. In this study investigators are randomizing patients with major pancreatic surgery in to two groups. Intervention group will start no-fat diet, including MCT-oil, right after surgery up to 2 weeks. And control group will start the diet if chyle-leak is seen. End goal is to reduce chyle-leaks in post-operative patients and analyze if it has an effect on patients prognosis.

详细描述

Patient who come for pancreatic surgery and vein resection/reconstruction will be randomized before surgery in two groups. Intervention group will start the no-fat diet right after surgery, with MCT-oil supplement. Diet will be continued up to 14 days after surgery. The control group will start the diet if chyle leak is diagnosed. Criteria of chyle leak in this study is appearance of milky-coloured fluid from the surgical drains in post-operative day 3 and drain fluids triglyceride levels must be high (>1,5 mmol/l). After enough patients have been recruited in the study, patient records are then analyzed to see if the no-fat diet has any effect on incidence of chyle-leak.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Need for a pancreatic resection with vessel resection/reconstruction

排除标准

  • No pancreatic and vessel resection needed
  • Patients do not want to join the study

结局指标

主要结局

Chyle-leakage reduced from operating area after surgery

时间窗: 2 weeks after surgery or when patient is released from hospital, in the case of prolonged hospital-stay due to complications, is patient data being analyzed

Post-operative chyle leak is diagnosed if drain fluids triglyserid content is above normal at post-operative day 3 (\> 1,5mmol/l).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tiina Vuorela

MD, PHd student, Junior surgeon

Helsinki University Central Hospital

研究点 (1)

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