Implementation of a Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis Prior to Hepatectomy: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Perioperative blood transfusion
研究概览
简要总结
Non-alcoholic fatty liver disease is becoming increasingly common in Canada and throughout the world. Fatty liver can increase the risks of perioperative complications for those who need liver surgery. A ketogenic diet is low in carbohydrates and can be very effective in reducing liver fat content. The purpose of this randomized control trial is to compare the effect of a short duration (4 week) preoperative ketogenic diet on operative and disease outcomes in patients undergoing liver surgery. One arm will be randomized to the ketogenic diet and the other will receive standard of care pre-operative dietary consultation.
详细描述
The rise in obesity has contributed to increasing rates of non-alcoholic fatty liver disease (NAFLD) in Canada and globally. In the setting of liver surgery, fatty liver has been associated with higher rates of blood loss during surgery as well as higher rates of postoperative complications. A pre-operative ketogenic diet (KD) has been proposed as a strategy to decrease the risks of fatty liver in patients undergoing liver surgery and has shown promising results in reducing liver fat content, even with short-duration diets. The current literature contains a large variety of pre-operative diets aimed at reducing liver fat content and most studies are observational. Presently, there is no randomized control trial looking at the effects of a well-formulated and standardized KD prior to liver surgery and its effect on operative and disease outcomes. This study will randomize patients with NAFLD needing surgery to remove liver tumors to either the control group or intervention group. Patients in the control group will receive dietary consultation for a standard of care diet as recommended by Canada's Food Guide. Patients in the intervention group will consult with a dietician before starting a 4-week preoperative well-formulated very low carbohydrate KD. All participants will track daily nutritional intake and provide weekly summary reports via an app called Cronometer. The investigators will analyze differences in intraoperative blood loss and OR time, postoperative complications, disease recurrence and mortality rates between the two groups.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
The surgeons, surgical team, and data abstractors will be blinded to participant randomization
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
- •Patients 18 years of age or older undergoing any type of liver resection (e.g. wedge, formal hepatectomy), either open or laparoscopic, for colorectal liver metastases (CRLM)
- •Patients with evidence of hepatic steatosis on pre-operative imaging (CT or MR) or biopsy.
- •Ability to use an app based nutritional program to track macronutrient uptake throughout the dietary intervention.
排除标准
- •Patients undergoing liver resection for any other indication
- •Patients on sodium glucose co-transporter 2 (SGLT-2) inhibitors (these are contraindicated with a ketogenic diet).
- •Patients without evidence of hepatic steatosis.
- •Patients with evidence of liver fibrosis or cirrhosis on preoperative bloodwork or imaging.
- •Patients with alcohol-related hepatic steatosis.
- •Patients with a known bleeding disorder.
研究组 & 干预措施
Control Arm
Participants in this group will be counselled by a registered dietician and then undergo a 4-week standard of care diet, as recommended by Canada's Food Guide. They will record all nutritional uptake during the diet using an app called Cronometer and provide weekly summary reports to the study team.
Ketogenic Diet Arm
Participants in this group will be counselled by a registered dietician and then undergo a 4-week preoperative well formulated ketogenic diet. They will record all nutritional uptake during the diet using an app called Cronometer and provide weekly summary reports to the study team.
干预措施: Ketogenic Diet (Dietary Supplement)
结局指标
主要结局
Perioperative blood transfusion
时间窗: postoperative days 0-7
receipt (binary) of packed red blood cell (pRBC) units intraoperatively and during the immediate postoperative time period (POD 0 - 7)
次要结局
- Amount of perioperative blood transfusion(postoperative days 0-7)
- Cancer-related mortality(0 - 5 years postoperatively)
- Postoperative mortality(Postoperative days 0-30)
- Intraoperative blood loss(Operative period)
- Steatosis(Time of primary surgery)
- Change in steatosis(~6 weeks)
- Operative time(During primary surgery)
- Postoperative complications(Postoperative days 0-30)
- Measurement of circulating cell-free tumor DNA(0 - 5 years postoperatively)
- Postoperative hospital readmission(Postoperative days 0-30)
- Postoperative liver failure(Postoperative days 0-30)
- Adherence to ketogenic diet(4 weeks)
- Postoperative length of hospital stay(Postoperative days 0-30)
- Postoperative rates of reoperation(Postoperative days 0-30)
- Disease recurrence(0 - 5 years postoperatively)
研究者
Anton Skaro
Associate Professor Dept of Surgery
Western University, Canada