Recruiting nowNot phasedRandomised
What this trial is trying to do
The researchers expect that a four-week ketogenic diet, which sharply limits carbohydrates and may reduce fat stored in the liver, could make liver surgery safer. The trial is testing this against standard preoperative dietary advice.
They want to know whether reducing liver fat before surgery leads to fewer perioperative complications, with blood transfusion during or around the operation as the main measure. The comparison is with usual preoperative dietary consultation, rather than with another drug or operation.
Worth knowing: The main outcome is blood transfusion, which is a measure of surgical safety rather than how long people live or how long the cancer stays controlled.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05884723 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, blinded |
| Taking part | 124 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Anton Skaro |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Supplement Ketogenic Diet
What it is measuring
Perioperative blood transfusion
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: Canada.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05884723, registered by Anton Skaro on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.