Palliative Care for Advanced Liver Disease

(LiverPAL Trial)

Overseen By Grace Bizup, 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

Trial Summary

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 data supports the effectiveness of the treatment LiverPAL for advanced liver disease?

Palliative care has been shown to improve symptoms and end-of-life care for patients with cancer, and it is beneficial in end-stage liver disease, suggesting that similar benefits might be expected for advanced liver disease. ^{1 2 3 4 5}

Is palliative care safe for people with advanced liver disease?

The research does not provide specific safety data for palliative care in advanced liver disease, but it is generally used to improve quality of life and manage symptoms in serious illnesses. ^{3 4 5 6 7}

How is the LiverPAL treatment different from other treatments for advanced liver disease?

LiverPAL is unique because it focuses on providing palliative care (care that improves quality of life by reducing symptoms) specifically for patients with advanced liver disease, a group that often lacks access to such care. Unlike standard treatments that primarily address the liver disease itself, LiverPAL aims to improve the overall well-being and comfort of patients by addressing their significant symptom burden. ^{1 3 4 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

Research Team

Nneka Ufere, MD MSCE

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

Ability to comprehend English and can complete questionnaires

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

Ability to comprehend English

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Palliative Care Consultations for Hospitalized Patients With Liver Disease. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis. [2021]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Palliative Care, Patient-Reported Measures, and Outcomes in Hospitalized Patients With Cirrhosis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Identifying palliative care needs in a Portuguese liver unit. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Emerging Role of Palliative Care in Patients with Advanced Liver Disease. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Emotional experience of people with advanced liver disease: Secondary data analysis. [2021]