London Health Sciences Centre/Western University
London, Ontario, N6A 5A5, Canada
Location status: Recruiting
NCT Number: NCT05884723
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
London, Ontario, N6A 5A5, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: postoperative days 0-7
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
Number of pRBC units transfused
Time frame: Operative period
Intraoperative blood loss: measured by net sponge weight and fluid suctioned minus irrigation fluid
Time frame: Time of primary surgery
Level of steatosis in liver resection specimen
Time frame: ~6 weeks
Change in steatosis in liver pre-diet vs day of surgery
Time frame: During primary surgery
time from surgery start to surgery stop
Time frame: Postoperative days 0-30
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 will be assessed.
Time frame: Postoperative days 0-30
Hospital readmission will be assessed within 30 days of the operation
Time frame: Postoperative days 0-30
Reoperation rates will be assessed within 30 days of the initial surgery.
Time frame: Postoperative days 0-30
Liver failure rates will be assessed within 30 days of the initial surgery.
Time frame: Postoperative days 0-30
Mortality rates will be assessed within 30 days of the initial surgery.
Time frame: 4 weeks
whether participants adhered to the diet assigned to them
Time frame: 0 - 5 years postoperatively
Time to disease recurrence will be assessed up to 5 years postoperatively.
Time frame: 0 - 5 years postoperatively
Circulating cell-free tumour DNA levels will be measured up to 5 years postoperatively.
Time frame: 0 - 5 years postoperatively
Cancer-related mortality rates will be assessed up to 5 years postoperatively.
Contact information is provided by the study sponsor or research team.
Anton Skaro, MD PhD
CONTACT
519-685-8500 ext. 32904
Crystal Engelage, PhD
CONTACT
519-685-8500 ext. 37517
Anton Skaro
Other
Implementation of a Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis Prior to Hepatectomy: a Randomized Control Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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