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Liver Transplantation clinical trials

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NCT ID: NCT05760235 Recruiting - Obesity Clinical Trials

Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Liver Transplant Candidates

ESGiTX
Start date: October 13, 2022
Phase: N/A
Study type: Interventional

The goal of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects with the need of liver transplantation to reduce their BMI in order to enter the waiting list (BMI (≥35 kg/m2). The main question[s] it aims to answer are: - Is the procedure effective in reducing BMI to the target level in 12 months? - Which is the effect on weight loss, quality of life and obesity-related comorbidities? Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation

NCT ID: NCT05754242 Recruiting - Clinical trials for Liver Transplantation

Ascorbic Acid to Prevent Postreperfusion Syndrome in Liver Transplantation

VITACTOH
Start date: November 17, 2020
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to test the efficacy of intravenous ascorbic acid in preventing the postreperfusion syndrome in liver transplantation. The main questions it aims to answer are: - Can intravenous ascorbic acid prevent postreperfusion syndrome in liver transplantation ? - Can ascorbic acid decrease the incidence of liver graft dysfunction after liver transplantation? - Can ascorbic acid decreased the incidence of postoperative complications after liver transplantation ? Participants will receive 1.5 g of intravenous ascorbic acid diluted in 100 ml of saline or 100 ml of saline alone, during the anhepatic phase of liver transplantation before reperfusion of the new graft. Researchers will compared the incidence of postreperfusion syndrome in both groups.

NCT ID: NCT05707520 Recruiting - Clinical trials for Liver Transplant Rejection

Long-term Benefit of MPA in Liver Transplantation

Start date: December 4, 2022
Phase:
Study type: Observational

MPA drugs are antiproliferative immunosuppressants and are widely used in solid organ transplantation. MPA drugs do not affect the recipient's kidney function and do not cause metabolic abnormalities and other problems. Intestinal solvent-based MPA drugs are widely used in clinical practice by improving the dosage form, reducing the irritation of MPA to the mucosa of the digestive tract, improving the tolerability of patients and maintaining a sufficient amount of MPA. However, data on the use/long-term use of intestinal solvent-based MPAs in liver transplant recipients are lacking. The study aims to evaluate the long-term benefits of enteric-coated mycophenolic acid in liver transplant recipients.

NCT ID: NCT05700799 Recruiting - Pediatric ALL Clinical Trials

HEalth Advocate for Liver Transplant - Pilot

HEAL-Tx Pilot
Start date: March 9, 2023
Phase: N/A
Study type: Interventional

The Health Advocate for Liver Transplant (HEAL-Tx) Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for pediatric liver transplant patients and measure acceptability and feasibility according to RE-AIM.

NCT ID: NCT05680246 Recruiting - Clinical trials for Liver Transplantation

Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Donor Livers (DHOPEPROLONG)

DHOPEPROLONG
Start date: January 1, 2023
Phase:
Study type: Observational [Patient Registry]

End-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. End-ischemic DHOPE can be used to prolong donor liver preservation time for up to 24 hours. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), scientific evidence for prolonged DHOPE has currently reached stage 3. Assessment of long-term outcomes after prolonged DHOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking.

NCT ID: NCT05666453 Recruiting - Clinical trials for Liver Transplantation

A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in ABO-Incompatible Liver Transplantation

Start date: April 25, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj. administered for consecutive 3 days in adult subjects to prevent biliary complications after ABO incompatible adult to adult living donor liver transplantation (LDLT). The primary objective of this study is to determine the incidence rate of biliary complications for 48 weeks after liver transplantation. Incidence rate of transplant rejection, DSA, antibody reaction, CMV infection, infectious complications, DIHBS and recurrence rate of HCC as well as adverse events are assessed as additional efficacy and safety endpoints in this study.

NCT ID: NCT05647733 Recruiting - Clinical trials for Liver Transplantation

Restrictive Fluid Management In Liver Transplantation (REFIL)

REFIL
Start date: April 25, 2023
Phase: N/A
Study type: Interventional

Hypothesis: A Canadian multicentre clinical trial is feasible. Study Design: Multicenter internal pilot parallel arm randomized controlled trial Study population: Patients with end-stage liver disease undergoing a liver transplantation not meeting any exclusion criteria. Primary endpoint: The primary feasibility endpoint is an overall recruitment rate ≥ 4 patients/month across all three participating sites. Secondary endpoint: The secondary feasibility endpoints are a protocol adherence > 90%, a 30-day (or hospital discharge) and 6-month outcome measurement > 90%, and a mean difference in total intraoperative volume received (crystalloids and colloids combined) > 1000 ml between groups. Study intervention: Low splanchnic blood volume restrictive fluid management strategy (intervention). A phlebotomy, performed prior to dissection and transfused back after graft reperfusion, combined with a hemodynamic goal-directed restrictive fluid management strategy Optimized cardiac-output liberal fluid management strategy (control) A hemodynamic goal-directed liberal fluid management strategy that optimizes cardiac output throughout surgery

NCT ID: NCT05588271 Recruiting - Clinical trials for Liver Transplantation

A New Prediction Mode for Predicting the Risk of Pressure Injury in Patients Undergoing Liver Transplantation

PMPRPIULT
Start date: October 20, 2022
Phase:
Study type: Observational

Pediatric population is at a high-risk of pressure injury (PI). Patients undergoing liver transplantation are more prone to PIs compared with other types of surgery. However, there is a lack of sensitive and specific assessment tools for the risk of PI in patients undergoing liver transplantation. How to accurately predict the incidence of PI in patients undergoing liver transplantation is needs to be urgently eliminated. The study is conducted in the Renji Hospital, School of Medicine, Shanghai Jiaotong University which is the largest liver transplantation center in China.

NCT ID: NCT05574361 Recruiting - Clinical trials for Liver Transplantation

Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)

PILOT™_CA
Start date: September 19, 2022
Phase: N/A
Study type: Interventional

To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial

NCT ID: NCT05572528 Recruiting - Clinical trials for Hepatocellular Carcinoma

Lenvatinib Therapy in HCC Patients After LDLT

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

New guidelines have been successfully established to distinguish the patients who were suitable for LT. This is important for long-term recurrence free and overall survival rate. We stratified patients with PET diagnosis and fetal protein response to confirm if they were the high-risk group for HCC recurrence. According to our new guidelines, high-risk tumor biology and tumor necrosis have important indicators for improving overall survival. Response to topical therapy is associated with tumor biology and post-transplant recurrence risk. In addition, the challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Using the advance proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. It can be used to get a better treatment response and tumor necrosis before LDLT. As a result, it will improve recurrence-free survival and overall survival rate, especially in high-risk groups. In addition, lenvatinib is approved for using in patients with advanced liver cancer because its overall survival rate is not less than sorafenib in clinical trials. A new generation of targeted therapies will be applied to adjuvant therapy after LDLT.