Liver Cancer Clinical Trial
Official title:
Abdominal Regional Perfusion in Donation After Cardiac Death for Multi-Organ Transplantation
NCT number | NCT03946852 |
Other study ID # | 113712 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2019 |
Est. completion date | June 2026 |
The main purpose of this study is to increase the pool of organs available for donation by performing ARP to recondition donation after cardiac death (DCD) organs prior to transplantation. We will compare the outcomes of our ARP DCD liver transplants with historical data to determine the efficacy of this treatment compared to transplantation with standard DCD and donation after brain death (DBD) organs. We will also analyze biological samples from donors and recipients and compare them with outcome data in an effort to determine if any biological markers are able to predict the quality/success of the grafts.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | June 2026 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Recipient Criteria: Inclusion Criteria- Indications for Liver transplant include decompensated Cirrhosis of any etiology Model for End-Stage Liver Disease (MELD) score > 15 with no contraindications to liver transplant as per conventional clinical practice. Acute or fulminant liver failure Advanced malignancy such as HCC, cholangiocarcinoma, neuroendocrine tumor, or other cancer meeting criteria for listing and exception points as per current clinical guidelines. Exclusion Criteria- - Inadequate social support for liver transplant - Non-compliance with alcohol or narcotic cessation - Evidence of uncontrolled infection - Other untreated malignancy aside from those listed above - Physiologic evidence of frailty based on timed up and go, grip strength, 6 minute walk test, and cognitive testing. Donor Criteria: DCD donors offered via TGLN will be considered for assessment via abdominal regional perfusion based on the following parameters. These are in keeping with current criteria for abdominal organ donors. - Age: Up to 70 years of age within the initial evaluation period, with plans to expand to 75 y/o if initial results are favourable. - BMI: Donor BMI must be less than 30 for consideration - DCD donation criteria: Conventional criteria for DCD donation must be met, including no expectation for viable recovery, without meeting criteria for brain death, and expressed desire by family for organ donation. - Comorbidity: In the opinion of the on-call transplant surgeon, there should not be excessive comorbidity to exclude organ donation - Active infection: There should be no untreated infection. - Malignancy: Donors should have no evidence of active malignancy, or in the case of a treated malignancy there should be sufficient interval to rule out recurrence. In select cases, donors with tumors known to be indolent may be considered on a case by case basis. Liver transplant release Criteria: One of the major advantages of ARP beyond reconditioning the organ prior to cold storage and transplant, is an opportunity to assess graft function in-situ prior to transplant. The existing literature supports the use of multiple readily available laboratory tests to evaluate graft function prior to transplant. Donor labs will be drawn every 30 minutes from the perfusion circuit to evaluate organ function. - Transaminase: Initial transaminases (AST and ALT) drawn at the start of perfusion must be less than 4 times the upper limit of normal and stay below this threshold throughout the reperfusion process to be considered for use with an absolute cut-off of 500 - Lactate: Grafts will only be used if lactate levels do not rise during perfusion, ideal organs will have a decrease in serum lactate levels by 1.11 mmol/L per hour - Macroscopic appearance: On clinical evaluation, there should be no evidence of fibrosis or cirrhosis and organs should not have a macroscopically steatotic appearance. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
London Health Sciences Centre |
Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5. Review. — View Citation
Hessheimer AJ, García-Valdecasas JC, Fondevila C. Abdominal regional in-situ perfusion in donation after circulatory determination of death donors. Curr Opin Organ Transplant. 2016 Jun;21(3):322-8. doi: 10.1097/MOT.0000000000000315. Review. — View Citation
Jay CL, Lyuksemburg V, Ladner DP, Wang E, Caicedo JC, Holl JL, Abecassis MM, Skaro AI. Ischemic cholangiopathy after controlled donation after cardiac death liver transplantation: a meta-analysis. Ann Surg. 2011 Feb;253(2):259-64. doi: 10.1097/SLA.0b013e318204e658. — View Citation
Ruiz P, Gastaca M, Bustamante FJ, Ventoso A, Palomares I, Prieto M, Fernández JR, Salvador P, Pijoan JI, Valdivieso A. Favorable Outcomes After Liver Transplantation With Normothermic Regional Perfusion From Donors After Circulatory Death: A Single-center Experience. Transplantation. 2019 May;103(5):938-943. doi: 10.1097/TP.0000000000002391. — View Citation
Watson CJE, Hunt F, Messer S, Currie I, Large S, Sutherland A, Crick K, Wigmore SJ, Fear C, Cornateanu S, Randle LV, Terrace JD, Upponi S, Taylor R, Allen E, Butler AJ, Oniscu GC. In situ normothermic perfusion of livers in controlled circulatory death donation may prevent ischemic cholangiopathy and improve graft survival. Am J Transplant. 2018 Dec 27. doi: 10.1111/ajt.15241. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Biliary anastomotic stricture | Imaging or biochemical evidence of anastomotic stricture requiring intervention | 1 year | |
Other | Biliary Anastomotic leak | Imaging or endoscopic evidence of bile leak requiring antibiotics or percutaneous drainage | 30 days | |
Other | Length of ICU stay | Duration of post-operative stay in ICU | 30 days | |
Other | Overall Length of stay | Overall duration of stay in hospital post-transplant | 30 days | |
Other | Re-operation rate | Frequency of return to the operating room for any reason | 30 days | |
Primary | Primary non-function | Graft failure requiring re-transplantion | 1 week | |
Primary | Early allograft dysfunction | Transient non-functioning of the liver transplant but with usual recovery to full functioning liver | 1 week | |
Primary | Ischemic Cholangiopathy | Non-anastomotic biliary stricture without other identifiable etiology | 1 week to 12 months post transplant | |
Secondary | Overall patient survival | Patient Mortality at any time post transplant | 1 and 5 years | |
Secondary | Graft survival | Need for retransplant secondary to graft failure of any cause, or death | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03756597 -
PAN-study: Pan-Cancer Early Detection Study (PAN)
|
||
Recruiting |
NCT05160740 -
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer
|
N/A | |
Completed |
NCT01906021 -
Study of New Software Used During Ablations
|
N/A | |
Terminated |
NCT04589884 -
Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
|
||
Recruiting |
NCT05953337 -
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
|
N/A | |
Enrolling by invitation |
NCT04466124 -
Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy
|
||
Not yet recruiting |
NCT04053231 -
Hepatocarcinoma Recurrence on the Liver Study - Part2
|
||
Active, not recruiting |
NCT02869217 -
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
|
Phase 1 | |
Completed |
NCT03059238 -
Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure
|
Phase 3 | |
Recruiting |
NCT02632188 -
Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT01388101 -
Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor)
|
N/A | |
Completed |
NCT01042041 -
Sorafenib Tosylate and Chemoembolization in Treating Patients With Unresectable Liver Cancer
|
Phase 1 | |
Terminated |
NCT00903396 -
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
|
Phase 2 | |
Completed |
NCT00980239 -
HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver
|
Phase 1 | |
Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
Completed |
NCT00543777 -
Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
|
Phase 1/Phase 2 | |
Terminated |
NCT00896467 -
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
|
N/A |