PATIENTS

LIVERATION’s aim is to lower the chances of liver cancer coming back after surgery in the surgical bed, improve survival rates, and enhance quality of life for people with colorectal cancer with liver metastasis or hepatocarcinoma. We also want to learn more about how patients feel, and what they want and need while going through the surgery and recovery process. 

If you are interested in participating in the clinical trial, please contact a participating hospital in your country for more information here.

For patients who are already enrolled in the clinical trial, below we provide information on how to prepare for surgery, what to expect on the day of the surgery and during the hospital stay, and what to expect after the surgery.

If there is other information you need or resources you would like us to share, please feel free to contact us.

Patients and other relevant stakeholders can also get involved in the project by participating in the European-level Multistakeholder Group  or the Living Labs. 

Ultimately, LIVERATION findings will inform the development of an Interactive Decision Tool  to be used by patients and professionals that aims to help guide the decision-making process.  

This page will be continuously updated based on stakeholders’ feedback. 

Patients and other stakeholders’ involvement in LIVERATION

Liver Cancer Clinical trial

  • Overview

Timeline: 2023 – 2028 

The LIVERATION trial is focused on patients with a primary liver cancer such as hepatocarcinoma or patients with colorectal cancer with liver metastases undergoing a liver resection (See Clinical Sites for more information on participating hospitals in Spain, France, Italy, Slovenia, Poland, Switzerland and Greece). More information here

European-level Multistakeholder Group

Timeline: 2023 – 2028 

We developed a detailed stakeholder analysis to define and establish LIVERATION’s European multi-stakeholder group.  

It will involve citizens and patients, family and caregivers, health and care professionals, industry, hospital managers, ethicists, public authorities and regulators in three online iterative discussions and co-creation activities. More information here.

Living Labs

Timeline: 2025 – 2026 

Living labs are creative spaces where different groups of stakeholders come together to co-create innovations that will address current needs in real-world contexts (U4IoT Consortium, 2017). More information here.

Interactive Decision Tool

Timeline: 2026 – 2028 

Healthcare decision aids help inform patients and professionals about different evidence-based healthcare options to tailor clinical decisions to individual patient’s needs and preferences. They support evidence-based decision making and have been shown to increase patient knowledge. More information here.

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.
  1. 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. 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. Fasting may range from 6 to 12 hours before the procedure. 
      1. 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. 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. 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. If you are in the study group, the ACM technique will be used in addition to the conventional surgery and coagulation methods. 
      2. 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. 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

European-level Multistakeholder Group

These three rounds of discussions will discuss topics such as: understanding patient priorities, meeting professionals’ needs to promote the adoption of LIVERATION techniques, understanding the requirements from regulatory agencies in different countries, exploring potential socio-ethical concerns across different LIVERATION sites and countries, considering issues of fairness and access to healthcare, amongst others. 

  • Round 1: We will begin by understanding the challenges, needs, and obstacles faced by each of the stakeholder groups we’ve identified.
  • Round 2: Next, we will collectively discuss and agree upon the main challenges and potential solutions.
  • Round 3: Finally, we will work together to reach a consensus on the primary areas that will be addressed through our action plan, guidelines, and recommendations.

Are you a potentially relevant stakeholder for our group and want to join us?  

Please contact us here and we will further share with you how to apply! 

Living labs

During LIVERATION, we aim to co-create clinical living labs in one hospital per participating country to identify and prioritize end-user needs and preferences related to quality of life, patient experience, and stakeholder engagement. We will integrate findings from.

1) the patient-reported health-related quality of life and experience questionnaires.

2) interviews with patients, patient representatives, caregivers, professionals and other relevant stakeholders, and

3) co-design groups. Findings from the living lab design process will be shared with the European-level multistakeholder group to attain feedback and vice versa. 

Interactive Decision Tool

The interactive decision tool will be developed based on previous LIVERATION findings including the results from a systematic review of the literature, the clinical trial, patient-reported health-related quality of life and patient experience, the European-level multistakeholder group and the living labs. 

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