UPMC Thomas E. Starzl Transplantation Institute Innovative and Novel Indications for Live Donor Liver Transplant (LDLT)

Similar documents
Live Donor Liver Transplantation: A Life Saving Option for End Stage Liver Disease

Ontario s Adult Referral and Listing Criteria for Liver Transplantation

Patients must have met all of the following inclusion criteria to be eligible for participation in this study.

Workup of a Solid Liver Lesion

Liver Transplantation Evaluation: Objectives

Primary Sclerosing Cholangitis and Cholestatic liver diseases. Ahsan M Bhatti MD, FACP Bhatti Gastroenterology Consultants

Evaluation Process for Liver Transplant Candidates

Your Health Matters. What You Need to Know about Adult Liver Transplantation. Access our patient education library online at

Evaluation Process for Liver Transplant Candidates

ASSESSMENT AND MANAGEMENT OF POTENTIAL LIVER TRANSPLANT CANDIDATES

Evaluating HIV Patient for Liver Transplantation. Marion G. Peters, MD Professor of Medicine University of California San Francisco USA

Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer

Liver Transplantation

Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Liver Transplantation: The End of the Road in Chronic Hepatitis C Infection

location and services guide

Ontario s Referral and Listing Criteria for Adult Kidney Transplantation

R.Sotoudehmanesh, MD Professor of Gastroenterology Digestive Disease Research Institute Tehran University of Medical Sciences Pancreatobiliary

Index. Surg Oncol Clin N Am 16 (2007) Note: Page numbers of article titles are in boldface type.

Management of colorectal cancer liver metastases

Epidemiology, aetiology and the patient pathway in oesophageal and pancreatic cancers

MUSCLE - INVASIVE AND METASTATIC BLADDER CANCER

Interventional Radiology in Liver Cancer. Nakarin Inmutto MD

CHK1 Inhibitor. Prexasertib, LY MsOH H 2 O. Drug Discovery Platform: Cancer Cell Signaling

Noncalculous Biliary Disease Dean Abramson, M.D. Gastroenterologists, P.C. Cedar Rapids. Cholestasis

LiverGroup.org. Case Report Form (CRF) for STAGED procedures

Panitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients

Reference: NHS England B01X26

Position Paper of the Italian Association for the Study of the Liver for the rational use of anti-hcv drugs available in Italy

Liver Transplant and Combined Liver-Kidney Transplant

End Stage Liver Disease & Disease Specific Indications for Liver Transplant. Susan Kang, RN, MSN, ANP-BC

End Stage Liver Disease & Disease Specific Indications for Liver Transplant Susan Kang, RN, MSN, ANP BC

Hepatocellular Carcinoma: Diagnosis and Management

Hepatobiliary Malignancies Retrospective Study at Truman Medical Center

Medical Writers Circle October 2008

MANAGEMENT OF COLORECTAL METASTASES. Robert Warren, MD. The Postgraduate Course in General Surgery March 22, /22/2011

1. Discuss the basic pathophysiology of end-stage liver and kidney failure.

Hepatobiliary and Pancreatic Malignancies

CHOLANGIOCARCINOMA (CCA)

Case 1 AND. Treatment of HCV: Pre- vs Post- Transplant. 58 yo male, ESRD/diabetic nephropathy, HD for 3 weeks

The Continuum of Care for Advanced Liver Disease: Partnering with the Liver Specialist. K V Speeg, MD, PhD UT Health San Antonio

GASTROINTESTINAL MALIGNANCIES

Hepatitis C Medications Hawaii PRIOR AUTHORIZATION REQUEST FORM

Related Policies None

Organ Donation & Allocation. Nance Conney Thomas E. Starzl Transplantation Institute

Related Policies: None

Tumor incidence varies significantly, depending on geographical location.

Liver Transplant. Description

Multidisciplinary Treatment Strategies for Primary and Metastatic Liver Cancers

During the course of the 12 month fellowship, candidates will attend at least one international liver meeting (generally AASLD).

By: Tania Cortas, MD Arizona Oncology 03/10/2015

Limitations - CEA Limitations Beta HCG

Manchester Cancer Colorectal Pathway Board: Guidelines for management of colorectal hepatic metastases

Surgical management of HCC. Evangelos Prassas Hepatobiliary and Pancreatic Surgery / Liver Transplantation Kings College Hospital / London

2018 OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY. MEASURE TYPE: Process

In- and exclusion criteria

Ontario s Referral and Listing Criteria for Adult Pancreas-After- Kidney Transplantation

Initial Evaluation for HCV Therapy. Hope McGratty PA-C, MPH

Trattamento chirurgico delle lesioni epatiche secondarie difficili. Adelmo Antonucci Chirurgia Oncologica e Epato-bilio-pancreatica

TA L K I N G A B O U T T R A N S P L A N TAT I O N

Primary Care Approach to Diagnosis and Management of Chronic Hepatitis C Brian Viviano, D.O.

Hepatitis C Virus (HCV)

DIFFERENTIAL BENEFITS OF DAAs IN DIFFERENT PATIENT POPULATIONS. IN PATIENTS ON A WAITING LIST FOR TRANSPLANTATION. THE CLINIC.

Navigating the Biliary Tract with CT & MR: An Imaging Approach to Bile Duct Obstruction

Cases: Treatment of Hepatitis C in Patients with Cirrhosis and Advanced Liver Disease

Liver Transplant MM /21/1999. HMO; PPO 09/01/2014 Section: Transplants Place(s) of Service: Inpatient

Management of Cholangiocarcinoma. Roseanna Lee, MD PGY-5 Kings County Hospital

Intron A Hepatitis C. Intron A (interferon alfa-2b) Description

Corporate Medical Policy Liver Transplant

Monitoring Patients Who Are Starting HCV Treatment, Are On Treatment, Or Have Completed Therapy

Figure 1: PALLAS Study Schema. Endocrine adjuvant therapy may have started before randomization and be ongoing at that time.

Learning Objectives. After attending this presentation, participants will be able to:

Organ Procurement and Transplantation Network

6 th August 2018 Day 1 - Gallbladder & Bile duct Topic

Corporate Medical Policy Liver Transplant and Combined Liver-Kidney Transplant

Primary Sclerosing Cholangitis Medical Management

Iowa Methodist Medical Center Transplant Center. Informed Consent for Kidney Transplant Recipient

Liver transplantation: Hepatocellular carcinoma

Living Donor Liver Transplantation NATCO Introductory Course

DISEASE LEVEL MEDICAL EVIDENCE PROTOCOL

IMPORTANT REMINDER DESCRIPTION

Management of Chronic HCV. Lauren Beste, MD MSc Hepatitis C Lead Clinician, VA Puget Sound July 23, 2013

Informed Consent for Liver Transplant Patients

Management of Hepatitis C in Primary Care BABAFEMI ONABANJO, MD & BEN ALFRED, FNP UMASS FAMILY HEALTH CENTER WORCESTER

Radiation Therapy for Liver Malignancies

Bariatric Surgery For Patients With End-Organ Failure

Alcoholism and Alcohol Liver Disease from a Transplant Hepatology Perspective

Hospice Eligibility August 2018

Title: What is the role of pre-operative PET/PET-CT in the management of patients with

Hepatitis C Policy Discussion

TREATMENT FOR HCC AND CHOLANGIOCARCINOMA. Shawn Pelletier, MD

Intron A (interferon alfa-2b) with ribavirin, (Copegus, Moderiba, Rebetol, Ribapak, Ribasphere, RibaTab, ribavirin tablets/capsules - all strengths)

Drug Discovery Platform: Cancer Cell Signaling. MET Inhibitor. Merestinib, LY Christensen JG, et al1; Eder JP, et al 2

Dr. Shari Srinivasan, Consultant Chemical Pathologist, Tallaght Hospital, Dublin 24, Ireland

Winter Videoconference Series

Guidelines for the Management of Renal Cancer West Midlands Expert Advisory Group for Urological Cancer

BK Viral Infection and Malignancy in Renal Transplantation ~A Case History~

Hepatitis B Virus. Taylor Page PharmD Candidate 2019 February 1, 2019

Transcription:

UPMC PRESBYTERIAN SHADYSIDE TRANSPLANT POLICIES AND PROCEDURES UPMC Thomas E. Starzl Transplantation Institute Innovative and Novel Indications for Live Donor Liver Transplant (LDLT) Alcoholic hepatitis HCC: Extended criteria Cholangiocarcinoma Jehovah s Witness ABO incompatible LDLT Unresectable colorectal metastases Low/ high MELD patients Simultaneous liver kidney Re-do liver transplants NET and other rare tumors HIV recipients Acute liver failure

Living-donor liver transplants offer life-saving advantages for patients on the liver transplant waiting list and those with a novel diagnosis. UPMC is a leading living-donor liver transplant center and when it comes the number of yearly cases, we are one of the top programs in the country. UPMC works with hospitals that have an existing liver transplant program collaboratively that want to provide patients the option of a living-donor liver transplant through UPMC s Complex Care Connect clinical partnership program for select cases.

Alcoholic Hepatitis (AH): Patients with excessive alcohol intake (>60 g/day in men and >40 g/day in women for at least 1 year) and recent onset of jaundice and liver related complications The episode of AH is the first liver-decompensating event Patients with severe AH as determined by (MELD>20), DF > 32, non-responders to prednisolone or contraindications to corticosteroid therapy Non responders of conventional medical therapy (corticosteroids or pentoxiphylline) after 1 week, as determined by a Lille Score of >0.45 (http://www.lillemodel. com/score.asp) Presence of close supportive family members, partners, or friends Absence of severe coexisting psychiatric disorders Favorable transplant social worker and psychologist evaluations Patients with non-severe AH at admission (i.e. MELD<20) that rapidly progress to a severe form (MELD>20) will also be considered as potential candidates if the criteria of disease severity persist after 1 week Acceptance of having an alcohol-related problem Willingness to engage into a long-term alcohol counseling therapy Existence of a caregiver that can provide care for up to 6 weeks Patients with previous hospitalization(s) for liver-related decompensations due to alcoholic liver disease (i.e. jaundice, variceal bleeding, edema/ascites, spontaneous bacterial peritonitis or encephalopathy) that continue to drink at any time after the first presentation Pre-existing chronic kidney injury (creatinine >2 mg/dl) or AKI during hospitalization requiring dialysis for more than 6 weeks All pre-existing and current medical conditions that are contraindications to liver transplant Previous failed alcohol detoxification/therapy programs Existence of severe coexisting psychiatric disorders (i.e. personality disorders, major depression, drug dependence, bipolar disorder, eating disorder) Current use of recreational drugs other than marijuana or tobacco

LDLT for Extended Criteria HCC No evidence of extrahepatic metastases No macrovascular invasion No systemic cancer related symptoms (ie significant muscle wasting and weight loss) No superimposed Cholangiocarcinoma AFP < 600 No limits in the number and size of HCC lesions, but patients with HCC outside UCSF criteria should get targeted biopsy of the largest lesion to assess tumor biology and suitability for transplant Targeted biopsy of the largest lesion showing poor differentiation of tumor Presence of extrahepatic disease and/or vascular invasion Poor performance status Any general contraindications for transplant Evidence of distance metastasis Presence of systemic cancer related symptoms AFP > 600 LDLT in Select Patients with Unresectable Metastatic Colorectal Cancer Histologically confirmed adenoca of the colon/rectum; primary resected with adequate margins (at least 2 cm for rectal ca) Primary colorectal cancer tumor stage is T4a or N1 Time from primary CRC resection to transplant is at least 6 months Received at least 6 to 12 weeks of chemotherapy with no evidence of disease progression No signs of local recurrence on colonoscopy, within the past 6 to 12 months before LT evaluation No signs of local or extra hepatic metastases on CT CAP / MRI/ PET CT, bone scan at time of LT evaluation Bilateral and non-resectable liver metastases No major vascular invasion Liver metastases; metastases isolated to liver Carcinoembryonic Antigen (CEA) < 100 ng/dl at time of LT evaluation No limit in terms of number or size of lesions Good ECOG performance (Eastern Cooperative Oncology Group) status: 0-1

ECOG (Eastern Cooperative Oncology Group) performance status > 2 Diagnosis of other malignancy within the past 2 years (excluding superficial skin and cervical cancers) Previous or current extra hepatic metastases or local recurrence Any general contraindication for liver transplantation BRAF mutant tumors Presence of adult immune deficiency syndrome (AIDS) LDLT for CholangioCarcinoma (CCA): Unresectable hilar CCA Diagnosis of CCA based on a malignant appearing stricture on cholangiography and one of the following: > > Biopsy or cytology results demonstrating malignancy > > CA 19-9 greater than 100 U/mL in absence of cholangitis > > Aneuploidy Extrahepatic disease, including LN involvement Tumor size >3 cm Previous attempted open biopsy or resection of tumor Intrahepatic metastases (contiguous intrahepatic metastases permitted) Vascular encasement NOT a contraindication Prior radiation therapy or chemotherapy Uncontrolled infection Peripheral CCA Contact Us For more information or to schedule an appointment, call 1-877-640-6746 or visit UPMC.com.

ABO incompatible LDLT The liver transplant candidate must be accepted for liver transplant listing by the UPMC liver transplant committee and deemed to be acceptable LDLT candidate Blood group A donors must be A1 ( A2 subtype donors will be treated as ABO compatible) Recipients must be capable and willing to undergo the more rigorous post liver transplant monitoring including all protocol liver biopsies Pre-liver transplant isoagglutinin titre must be < 1:8 after adequate plasmapheresis as needed Any other organ transplant other than liver Any recipient deemed not a candidate for transplant by the transplant team LDLT for HIV Recipients Documented HIV infection (by any licensed ELISA and confirmation by Western Blot) Current CD4+ T-cell count >100/mm3* times > 6 months. HIV-1 RNA < 400 for >3 months Patients considered for transplant must be naive either to one of the protease inhibitors (PI) or to one of the non-nucleoside reverse transcriptase inhibitors (NNRTI) for purposes of salvage therapy if required post transplant Willing to agree to start or re-start ARV therapy in the immediate post-operative period if not currently on ARVs secondary to intolerance caused by liver dysfunction Any history of any AIDS-defining opportunistic infection or neoplasm, except drug susceptible candida esophagitis History of any neoplasm except in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, or solid tumors treated with curative therapy and disease free for > 5 years Inability or unwillingness to comply with immunosuppression protocol, ARV therapy, and/or HCV monitoring and therapy if indicated Substance use including alcohol, illicit drugs, or abuse of prescription narcotics HIV genotype or phenotype demonstrating antiretroviral resistance in 3 drug classes (nucleoside reverse transcriptase inhibitors, non- nucleoside reverse transcriptase inhibitors, and protease inhibitors)

LDLT for High or Low MELD Recipients No upper or lower limit for MELD score Patients with low MELD score but with clinically significant symptoms of decompensated cirrhosis, e.g., Ascites, sacropenia, PSC patients with dominant stricture, hydrothrorax, debilitating HSE, HCC, difficult to manage GI bleeding, etc LDLT to be discussed with any patient disadvantaged due to the current MELD allocation system irrespective of their MELD score No upper MELD limit for transplant as long as they meet criteria for transplant in general and have a suitable donor LDLT for Jehovah s Witness Must fulfill all criteria for liver transplant candidacy Must meet the following minimum criteria: HCT > 35, Plt > 80K, INR<2 Must be willing to accept the use of Cellsaver and venovenous bypass intraoperatively Must be willing to have close follow-up preoperatively and postoperatively and comply with a medical regimen to maximize potential for successful transplant (such as iron therapy, epo, etc) Deemed not a candidate by the Liver Transplant Selection Committee or Live Donor Advocate based on medical, surgical, social or psychiatric criteria Does not meet the following minimal criteria: HCT > 35, Plt > 80K, INR<2 Does not have a potential living donor or potential donor who is willing to accept a blood transfusion Will not accept Cell Saver or use of bypass intraoperatively LDLT for Older Patient Cohort: LDLT can be offered to older patients > 65 with good performance status Depends on their conditioning, and overall general functional status Other Potential Indications: Simultaneous liver and kidney transplant: will require two separate living donors: for kidney and liver Re-do liver transplants: not a contraindication as long as they meet the criteria for a liver transplant

UPMC Thomas E. Starzl Transplantation Institute 3459 Fifth Ave. Pittsburgh, PA 15213 Phone: 1-877-640-6746 UPMC policy prohibits discrimination or harassment on the basis of race, color, religion, ancestry, national origin, age, sex, genetics, sexual orientation, gender identity, marital status, familial status, disability, veteran status, or any other legally protected group status. Further, UPMC will continue to support and promote equal employment opportunity, human dignity, and racial, ethnic, and cultural diversity. This policy applies to admissions, employment, and access to and treatment in UPMC programs and activities. This commitment is made by UPMC in accordance with federal, state, and/or local laws and regulations. TRANS506834 SR/EB 05/18 2018 UPMC