Palliative Care for Advanced Liver Disease

(LiverPAL Trial)

Overseen By William Munroe, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Diuretics, Encephalopathy medications

Disqualifiers: Liver transplant, Cancer, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early palliative care can enhance life quality, mood, and communication for people hospitalized with advanced liver disease. Palliative care focuses on easing symptoms and helping patients manage serious illnesses. Participants will receive either standard liver care or standard care plus early palliative support (LiverPAL). This trial may suit those hospitalized with advanced liver disease and facing issues like fluid buildup, infection, or bleeding. As an unphased trial, it offers a unique opportunity to explore the potential benefits of early palliative care without traditional phase constraints.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that early palliative care is safe for patients with advanced liver disease?

Research shows that palliative care, which eases symptoms and supports people with serious illnesses, is generally safe for patients with advanced liver disease. Studies have found that it improves symptom control without causing harm, indicating patients tolerate it well. Evidence suggests that palliative care enhances the quality of life for those with end-stage liver disease. This includes better management of physical symptoms and mood, with no significant negative side effects reported. Overall, the evidence supports adding palliative care as a safe choice for those with advanced liver disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the integration of early palliative care with usual hepatology care for patients with advanced liver disease. Unlike standard treatments, which typically focus on managing liver function and complications, this approach emphasizes improving quality of life and providing comprehensive support from an earlier stage. By introducing palliative care early, the trial aims to address symptoms, emotional well-being, and overall patient satisfaction, which are often overlooked in traditional care models. This could lead to a more holistic treatment strategy that not only prolongs life but also enhances the quality of living for patients.

What evidence suggests that early palliative care is effective for advanced liver disease?

Research has shown that starting palliative care early in the treatment of advanced liver disease can greatly enhance patients' quality of life. In this trial, participants will receive either usual hepatology care or usual hepatology care with early palliative care. Studies have found that palliative care helps manage symptoms like pain and discomfort. It also improves communication about serious illness, reducing stress for patients and their families. Evidence suggests that patients receiving palliative care feel better overall compared to those who do not. This care focuses on reducing symptoms and improving mood, making it a valuable option for patients with advanced liver disease. ^{1 2 3 6 7}

Who Is on the Research Team?

Nneka Ufere, MD MSCE

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for English-speaking patients hospitalized with advanced liver disease, which includes conditions like overt hepatic encephalopathy (needing medication), ascites (requiring water pills or repeated fluid removal procedures), hepatic hydrothorax (needing water pills), variceal bleeding (one or more episodes), and spontaneous bacterial peritonitis.

Inclusion Criteria

I have advanced liver disease and was hospitalized for it in the last 6 months.

Ability to comprehend English

I have an adult caregiver who can be with me during my treatments or join by phone.

Exclusion Criteria

I have had a liver transplant in the past.

Uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder, or other comorbid condition which prohibits the ability to provide informed consent

My liver cancer is more advanced than early stage criteria allow.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual hepatology care with or without early palliative care during hospitalization

Up to 6 months

Follow-up

Participants are monitored for quality of life, symptom management, and end-of-life care preferences

Up to 6 months

Long-term Follow-up

Assessment of end-of-life care and caregiver outcomes after patient death

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• LiverPAL

Trial Overview LiverPAL is being tested to see if starting palliative care early for hospitalized patients with serious liver diseases can help improve their quality of life, ease physical symptoms, better their mood, and enhance communication about their illness.

How Is the Trial Designed?

Group I: Usual Hepatology Care with Early Palliative Care Experimental Treatment 1 Intervention

Usual hepatology care with early palliative care

Group II: Usual Hepatology Care Active Control 1 Intervention

Usual hepatology care

LiverPAL is already approved in United States for the following indications:

Approved in United States as LiverPAL for:

• Advanced Liver Disease
• End Stage Liver Disease

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Palliative care (PC) consultations in hospitalized patients with cirrhosis often occur late in their hospital stay and are associated with more severe disease and functional impairments, highlighting a need for earlier intervention.

While PC was linked to fewer medical interventions like transfusions and endoscopies, it did not significantly impact readmissions, costs, or mortality, suggesting that further randomized trials are necessary to fully understand its benefits in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Care, Patient-Reported Measures, and Outcomes in Hospitalized Patients With Cirrhosis. Orman, ES., Yousef, A., Xu, C., et al.[2023]

In a feasibility trial involving 36 patients with end-stage liver disease, long-term abdominal drains showed lower hospital resource utilization and costs compared to large-volume paracentesis, suggesting they may be a more efficient option for managing refractory ascites.

While complications like cellulitis and leakage were more common in the long-term drain group (41% vs. 11% in the paracentesis group), the overall safety profile and high questionnaire completion rates indicate that patients found long-term drains acceptable and potentially transformative for their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis. Macken, L., Bremner, S., Gage, H., et al.[2021]

In a study of 44,933 hospitalized patients, those with liver disease were younger and had a higher in-hospital mortality rate (28%) compared to cancer patients (16.8%), highlighting the severity of liver disease in hospital settings.

Patients with liver disease were more likely to receive palliative care consultations focused on goals of care (81.7%) rather than pain management (10.9%), yet both groups showed similar improvements in symptoms and changes in resuscitation preferences after consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Palliative Care Consultations for Hospitalized Patients With Liver Disease. Ufere, NN., O'Riordan, DL., Bischoff, KE., et al.[2020]

Palliative care (PC) utilization for patients with alcohol-associated end-stage liver disease (ESLD) has significantly increased from 0.8% in 2007 to 6.6% in 2014, indicating a growing recognition of its importance in this population.

Patients receiving PC consultations had lower 30-day readmission rates, reduced hospitalization costs, and shorter lengths of stay, suggesting that PC can improve healthcare outcomes for those with decompensated alcohol-related liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective study on use of palliative care for patients with alcohol related end stage liver disease in United States. Gupta, K., Hans, B., Khan, A., et al.[2022]

Patients with advanced liver disease experience significant symptom burden and have considerable palliative care needs, highlighting the importance of improving their quality of life.

There is a global variability in the involvement of palliative care for these patients, indicating a need for further research and development of new care models to enhance access to specialist palliative services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Role of Palliative Care in Patients with Advanced Liver Disease. Jordan, RI., Tandon, P.[2021]

Patients with advanced liver disease often experience intense emotions such as fear, anger, sadness, and guilt, primarily triggered by factors like the shock of diagnosis and uncertainty about their illness.

Understanding these emotional responses is crucial for healthcare providers to offer holistic and supportive care, aligning with a palliative approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotional experience of people with advanced liver disease: Secondary data analysis. Gray-Renfrew, A., Kimbell, B., Finucane, A.[2021]

Palliative care is increasingly recognized as essential for patients with decompensated cirrhosis, particularly during advanced and terminal stages, yet it is often overlooked by hepatologists and liver transplant teams.

Recent guidance emphasizes a collaborative and standardized approach to palliative care, focusing on symptom management and end-of-life issues, which should be adopted by all healthcare workers involved in the care of cirrhotic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care in cirrhotic patients: Brief summary of recent AASLD guidance. Ozdogan, OC.[2022]

Out of 536 patients with advanced cancer, 45% were referred to palliative care (PC), with significant differences in access based on cancer type, particularly higher access for breast and gynecological cancers.

Patients referred to PC received less aggressive treatments, such as chemotherapy and intensive care, in their final weeks of life, indicating that PC may lead to a more comfortable end-of-life experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. Ledoux, M., Rhondali, W., Lafumas, V., et al.[2019]

In a study of 120 hospitalized patients with cirrhosis, 84.2% were identified as needing palliative care, but only 6.7% were referred for such services, highlighting a significant gap in care.

The NECPAL CCOMS-ICO© tool effectively identified palliative care needs, with excessive use of healthcare resources strongly correlating with the need for palliative intervention, suggesting it could improve patient outcomes if utilized more widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying palliative care needs in a Portuguese liver unit. Carvalho, JR., Vasconcelos, M., Marques da Costa, P., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-liver-diseases-8-2023-0f073

Palliative Care for Advanced Liver Disease (LiverPAL Trial) What data supports the effectiveness of the treatment LiverPAL for advanced liver disease? Palliative care has been shown to improve symptoms and end-of ...

2. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(22)00382-X/fulltext

Palliative care in advanced liver disease: time for action These trials will provide important data on the potential for palliative care interventions to improve outcomes for patients with advanced liver disease.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12176929/

Palliative care in terminally ill advanced chronic liver ... These studies will provide important data on the potential of palliative care interventions to improve outcomes for patients with ACLD [17].

4. sciencedirect.com sciencedirect.com/science/article/pii/S0885392425008711

Palliative Care for Advanced Liver Disease: Hepatology ... We conducted an embedded qualitative evaluation study, within the 19-site, randomized PAL-LIVER comparative effectiveness trial, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4229716/

Integration of Palliative Care in End-Stage Liver Disease ... In an analysis of 178 studies, 30% of ESLD patients with infections died within 30 days, another 30% within 1 year. Renal failure portends the worst outcome; ...

6. mdpi.com mdpi.com/2673-4389/5/3/39

Palliative Care in End-Stage Liver Disease A growing body of evidence reveals that palliative care has a positive impact on ESLD patients. This translates into improved symptom control of ESLD patients, ...

7. thelancet.com thelancet.com/pdfs/journals/langas/PIIS2468-1253(22)00382-X.pdf

Palliative care in advanced liver disease These trials will provide important data on the potential for palliative care interventions to improve outcomes for patients with advanced liver disease.