Liver Cancer Clinical Trial

Liver resection or hepatectomy is a surgical procedure that consists of removing part of the liver. LIVERATION’s primary objective is to evaluate the effectiveness of a new technique called additional coagulation of the margin (ACM) performed with a radiofrequency device combined with regular liver surgery in making a difference for people with liver cancer:  

Can using the ACM technique lower the chances of liver cancer coming back and improve survival rates? 

Patients taking part in the clinical trial will be divided into two groups, the control group and the study group:  

1. Control group: The control group will have the usual liver surgery and coagulation methods.

2. Study group: The study group will have the usual liver surgery and coagulation methods, in addition to the additional coagulation of the margin technique. Both groups will be followed up for several years to evaluate differences between groups over time. LIVERATION researchers will be tracking whether liver cancer comes back, survival odds, participants’ quality of life, as well as participants’ experiences related to the surgery and follow-up care, among other outcomes. 

• Risks / Benefits

Benefits of liver resection: Liver surgery can be curative and has the best survival rate, regardless of the type of procedure (laparoscopic, robotic or open procedure), compared with other cancer treatments. It is the best option to decrease the chances of liver cancer returning.

Risks or complications of liver resection: Liver resection is a complex surgical procedure. It has several possible complications, such as infection, bleeding, bile leakage, pleural effusion (buildup of fluid in chest), ascites (buildup of fluid in abdomen), deep vein thrombosis (blood clots), kidney failure and/or liver failure. Approximately 2% of people who have liver resection surgery may die of complications. Please contact your healthcare provider to help you weigh the benefits against the risks of liver resection surgery compared to liver cancer itself and other cancer treatments. We do not foresee any additional risks or complications for the study group related to the use of the additional coagulation of the margin (ACM) technique.

• Procedure

Preparing for surgery.

1. 1. 1. To determine if liver resection is the best treatment for you and help your healthcare provider team prepare for the surgery, you will likely:
      2. Have an appointment with an oncologist, a surgeon, and an anesthesiologist. 
      3. Be asked to take some of the following tests:

• • • Imaging tests (such as a CT scan or an MRI) 
    • Blood tests

• • • Liver biopsy (in some cases)
    • In preparation for your liver resection, it is important to eat healthy, get enough sleep and stay active. Your healthcare provider will help you modify any risk factors you may have prior to the surgery (e.g., tobacco use, alcohol consumption).

• What to expect on the day of the surgery.

The procedure for liver resection surgery may vary based on your condition, but in general, it follows these steps: 

1. 1. 1. Fasting may range from 6 to 12 hours before the procedure. 

1. 1. 2. Once in the operating room, you will be put to sleep under general anesthesia. Other anesthetic treatments may be used to help manage your pain after waking up. 

1. 1. 3. Based on your condition, the surgeon will perform the liver resection by open, laparoscopic or robotic approach. Open abdominal surgery requires one long incision in your abdomen, and it is used for more complex procedures. Laparoscopic and robotic surgeries are less invasive as they require four to six small incisions and are used for less complex liver resections. 

1. 1. 4. Then, the liver tumor will be identified and removed using regular liver surgery and coagulation methods. If the part of the liver that needs to be removed is close to the gallbladder or bile duct, they may be removed as well. 

1. 1. 5. If you are in the study group, the ACM technique will be used in addition to the conventional surgery and coagulation methods. 
      6. Finally, the surgeon will stitch up the layers of tissue of the abdominal cavity. The size of the incision will depend on the size of the tumor. 

1. 1. 7. The liver resection may last between 2 to 6 hours (or more) depending on the complexity of the procedure. You will wake up when the surgery has already ended. 

• What to expect during your hospital stay

• • • After the surgery, you will likely recover in a post-anesthesia unit or an intensive care unit to better monitor your clinical progress and then move to an in-patient room. You may have tubes to drain fluids, decompress your stomach and feed you that will be removed based on clinical progress. You will stay in the hospital for three to seven days depending on the operation, the incision size, and your general health.  During your hospital stay, you will begin to gradually eat solid food and move around more. You will receive pain medication during your recovery.  
    • When doctors consider you are ready to go home, you will be discharged with information related to care after surgery and outpatient appointments. Your first follow-up visit will be approximately one month after the surgery. 

•   What to expect at home.
  • Recovery:
    • During the first two weeks you will likely feel sore and tired and may also experience nausea, diarrhea, constipation, gas, low fever, or a headache. The skin around the incision may also feel numb. You may regain feeling over time, but it is likely for some numbness to remain.  
    • Recovery at home takes two to eight weeks depending on the type of procedure. People tend to recover faster from laparoscopic or robotic surgery (2-4 weeks) compared with open surgery (4-8 weeks). During this time, you should avoid heavy lifting and strenuous activities, and may need to be off work. 
    • It will take six to twelve weeks for you to return to your usual activities. 
    • Healthy liver tissue can partially grow back in a period of a few weeks to several months depending on your condition. 

• • Self-care: 
    • Diet: 

Have a healthy diet, including good protein intake, and drink enough fluids, preferably water. 

Avoid alcohol as alcohol can damage the liver.

• • • Activity: 

Listen to your body and rest when you need to. It is important to get enough sleep during your recovery.

Engage in gentle exercise daily, such as walking, and try to increase the amount you walk every day (30 minutes of walking is recommended).

Avoid strenuous activities including physical and sexual activity. Avoid heavy lifting, including avoiding lifting a child, heavy grocery bags and milk containers, a vacuum cleaner, etc. You will get recommendations on when to resume strenuous physical activity and sexual activity.

Practice breathing exercises.

Ask your doctor if and when you can shower and drive.

• • Incision care:
    • Wash the incision area every day with warm, soapy water, and pat it dry.
    • Keep the incision area dry and clean. 
    • Your nurses and doctors will give you more specific instructions on how to care for your incision. 

• • Medicines:
    • Take your pain medicines and other medicines exactly as indicated. 
    • Your doctor will tell you when to restart your other medicines and provide information about any new medicines.  
    • If you feel your medicines are making you sick or nauseous, contact your doctor.

• • Mental health:
    • Depression after surgery is a common experience. Symptoms may include excessive or difficulty sleeping, irritability, fatigue, loss of interest, helplessness, hopelessness, and/or loss of appetite for two weeks or more. Mental health screenings and realistic expectations can help you stay mentally healthy after surgery. You can also care for your mental health after surgery by:  
    • Preparing for your surgery by becoming well-informed and making a plan or having others help you plan for your care
    • Having live-in support or have others available to care for you emotionally and physically
    • Engaging in self-care (see Diet, Activity, Incision Care, and Medicines)
    • Getting social, economic and community help as needed (e.g., health insurance benefits, assistance with food or home care)
    • Checking your thoughts. Negative thinking is common after surgery. Acknowledge your thoughts and feelings, observe them, and let them pass by you. Try to replace negative thoughts with more realistic, helpful thoughts. Mindfulness may be helpful in dealing with negative thoughts.
    • Getting outside
    • Creating a team to support your mental health before, during, and after surgery. Inform your healthcare provider about your mental health.
    • If at any point you are in need of mental health support, contact your healthcare provider to obtain a referral to a mental health professional.  

• • When to call for help
    • You should contact your health provider or seek emergency care if:
      • You are bleeding or have discharge from your wound.
      • You have a persistent fever (38ºC or higher).
      • You experience vomiting or diarrhea.
      • You are constipated for more than 3 days.
      • Your abdomen is distended or swollen.
      • You have jaundice (yellow color in skin and eyes).
      • You have shortness of breath.
      • You have signs of a blood clot in your leg (pain in calf, back of knee, thigh, or groin, or redness and swelling in leg or groin)

• • References

• • • Government of Alberta and Alberta Health Services: https://myhealth.alberta.ca/Health/aftercareinformation/pages/conditions.aspx?hwid=zc2226 
    • Penn Medicine: https://www.pennmedicine.org/cancer/types-of-cancer/liver-cancer/liver-cancer-treatment/liver-resection 
    • Cleveland Clinic: https://my.clevelandclinic.org/health/treatments/22930-hepatectomy-liver-resection 
    • Psychology Today: https://www.psychologytoday.com/us/blog/two-takes-depression/202210/what-everyone-should-know-about-post-surgical-depression