Clinical trial NCT05884723: Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis
Official title: Implementation of a Preoperative Ketogenic Diet for Reduction of Hepatic Steatosis Prior to Hepatectomy: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Steatoses
Liver Metastasis Colon Cancer
NAFLD
Keywords: ketogenic diet
NAFLD
colorectal liver metastases
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: preoperative ketogenic diet group vs control standard of care preoperative diet
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Perioperative blood transfusion
timeFrame: postoperative days 0-7
Secondary outcomes:
measure: Amount of perioperative blood transfusion
timeFrame: postoperative days 0-7
measure: Intraoperative blood loss
timeFrame: Operative period
measure: Steatosis
timeFrame: Time of primary surgery
measure: Change in steatosis
timeFrame: ~6 weeks
measure: Operative time
timeFrame: During primary surgery
measure: Postoperative complications
timeFrame: Postoperative days 0-30
measure: Postoperative length of hospital stay
timeFrame: Postoperative days 0-30
measure: Postoperative hospital readmission
timeFrame: Postoperative days 0-30
measure: Postoperative rates of reoperation
timeFrame: Postoperative days 0-30
measure: Postoperative liver failure
timeFrame: Postoperative days 0-30
measure: Postoperative mortality
timeFrame: Postoperative days 0-30
measure: Adherence to ketogenic diet
timeFrame: 4 weeks
measure: Disease recurrence
timeFrame: 0 - 5 years postoperatively
measure: Measurement of circulating cell-free tumor DNA
timeFrame: 0 - 5 years postoperatively
measure: Cancer-related mortality
timeFrame: 0 - 5 years postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: London Health Sciences Centre/Lawson Health Research Institute
name: Anton Skaro, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: