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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
4-week preoperative well-formulated very low carbohydrate isocaloric diet consisting of 50g net daily carbohydrates and 1.5g/kg protein with the remaining energy needs consisting of primarily mono- and polyunsaturated fats
London Health Sciences Centre/Western University
London, Ontario, Canada
RECRUITINGPerioperative blood transfusion
receipt (binary) of packed red blood cell (pRBC) units intraoperatively and during the immediate postoperative time period (POD 0 - 7)
Time frame: postoperative days 0-7
Amount of perioperative blood transfusion
Number of pRBC units transfused
Time frame: postoperative days 0-7
Intraoperative blood loss
Intraoperative blood loss: measured by net sponge weight and fluid suctioned minus irrigation fluid
Time frame: Operative period
Steatosis
Level of steatosis in liver resection specimen
Time frame: Time of primary surgery
Change in steatosis
Change in steatosis in liver pre-diet vs day of surgery
Time frame: ~6 weeks
Operative time
time from surgery start to surgery stop
Time frame: During primary surgery
Postoperative complications
Postoperative complications (measured via the Clavien-Dindo Index) will be assessed within 30 days of the operation.
Time frame: Postoperative days 0-30
Postoperative length of hospital stay
Postoperative length of hospital stay will be assessed.
Time frame: Postoperative days 0-30
Postoperative hospital readmission
Hospital readmission will be assessed within 30 days of the operation
Time frame: Postoperative days 0-30
Postoperative rates of reoperation
Reoperation rates will be assessed within 30 days of the initial surgery.
Time frame: Postoperative days 0-30
Postoperative liver failure
Liver failure rates will be assessed within 30 days of the initial surgery.
Time frame: Postoperative days 0-30
Postoperative mortality
Mortality rates will be assessed within 30 days of the initial surgery.
Time frame: Postoperative days 0-30
Adherence to ketogenic diet
whether participants adhered to the diet assigned to them
Time frame: 4 weeks
Disease recurrence
Time to disease recurrence will be assessed up to 5 years postoperatively.
Time frame: 0 - 5 years postoperatively
Measurement of circulating cell-free tumor DNA
Circulating cell-free tumour DNA levels will be measured up to 5 years postoperatively.
Time frame: 0 - 5 years postoperatively
Cancer-related mortality
Cancer-related mortality rates will be assessed up to 5 years postoperatively.
Time frame: 0 - 5 years postoperatively
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