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Liver Transplantation clinical trials

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NCT ID: NCT05089604 Recruiting - Clinical trials for Liver Transplantation

Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations

LCP-TAC
Start date: January 9, 2023
Phase: Phase 4
Study type: Interventional

This is a randomized open label study in de novo liver transplant recipients that aims to compare the risk of tacrolimus induced tremors with once daily extended-release formulation, Envarsus, versus the twice daily immediate-release formulation. Both formulations of tacrolimus are currently approved for the prevention of rejection in liver transplant patients.

NCT ID: NCT05081141 Recruiting - Clinical trials for Kidney Transplant; Complications

HHV8 and Solid Organ Transplantation

Start date: September 15, 2021
Phase:
Study type: Observational

Solid organ transplant candidates will undergo serological screening for HHV8 at time of listing and transplantation. In the event of a recipient/donor mismatch R-/D+ or in the presence of a seropositive recipient (R+), blood levels of HHV8 DNA will be monitored together with specific IGRA for HHV8.

NCT ID: NCT05065125 Recruiting - Clinical trials for Liver Transplant; Complications

Clinical Usefulness of Digital Single-operator Cholangioscopy(SpyGlass™) for Post-liver Transplant Anastomotic Stricture

Start date: October 5, 2021
Phase:
Study type: Observational [Patient Registry]

Liver transplantation (LT) is an essential treatment for end-stage liver disease. Although clinical outcomes of LT recipients have markedly improved, anastomotic biliary strictures (ABS) are still occurred in 10-40% of post-LT patients. In the Korea, living donor LT (LDLT) is the more common than deceased donor LT (DDLT). When LDLT is performed, the right lobe graft is usually used, and the right anterior and posterior segmental bile ducts (RASD/RPSD) of the graft are reconstructed by the duct-to-duct anastomosis method to the common hepatic duct of the recipient. When ABS occurs in LDLT recipients, the stricture site is often very tight and twisted. So, conventional endoscopic procedure is challenging and success rate of ERCP for ABS is still unsatisfactory (about 60%). Furthermore, approach to the RPSD is more intricate than that to RASD because the duct opening is located deeper in a posterior aspect. Therefore, despite being able to benefit the patient, bilateral drainage (both RASD and RPSD) is considered to be more difficult and unilateral drainage of RASD is mainly performed. In 2015, high-resolution cholangioscopy (SpyGlass™) was introduced. The system enables direct visualization of the bile and pancreatic ducts strictures. The 3rd Generation SpyScope DS II Access & Delivery Catheter introduced in 2018, features increased resolution and adjusted lighting to provide physicians with an even better view of the biliary and pancreatic ducts. To date, only several retrospective studies have evaluated the efficacy of SpyGlass for guidewire placement across the ABS and to the best of our knowledge only one prospective study is ongoing (ClinicalTrials.gov NCT #03205072). In that study ABS in both LDLT and DDLT patients are enrolled. Private communications with the Sponsor of this study, however, have reported that only approximately 10% of the cases are LDLT cases. In addition, there is no reported paper about the usefulness of Spyglass for bilateral drainage and its clinical benefit in post LT ABS. If successful bilateral drainage is performed by using Spyglass, it may be more helpful for patients than unilateral drainage as it allows sufficient drainage of the transplanted liver. With this prospective study, we intends to investigate the efficacy of Spyglass for bilateral drainage of ABS in LDLT patients and improve drainage success rate. This results can be used as clinical basis for further studies such as randomized controlled trial.

NCT ID: NCT05051605 Recruiting - Liver Transplant Clinical Trials

Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation

Start date: September 15, 2021
Phase:
Study type: Observational

A prospective cohort study to evaluate the response to COVID-19 vaccine in liver transplantation patients.

NCT ID: NCT05042505 Recruiting - Diabetes Mellitus Clinical Trials

Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation

Dapa-LiT
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Patients with pre-transplantation type 2 diabetes (T2D) and new-onset diabetes post liver transplantation (NODAT) are managed with multiple doses of subcutaneous insulin (MSI) following liver transplantation. As these patients receive oral glucocorticoids (mostly prednisolone) and immunosuppressants, which elevate blood glucose levels, multiple doses of insulin are usually required. After 2-3 months, when steroid doses are tapered and doses of immunosuppressants stabilize, insulin requirements subside and several oral hypoglycemic agents are initiated, such as metformin and sitagliptin. However, these agents are prescribed off-label as the data regarding the safety and efficacy of these agents in patients with liver transplantation are scarce. Furthermore, several patients with liver transplantation develop fatty liver (liver steatosis) several months after transplantation, which is a risk factor for liver dysfunction. SGLT-2 inhibitors are reported to have favorable effect on liver fat accumulation in patients with T2D. However, the effect of SGLT-2 inhibitor on liver fat accumulation after liver transplantation has not been evaluated. Chronic liver disease is associated with changes in body composition, especially increase in visceral fat and decrease in skeletal muscle mass. Data regarding the changes in body composition following liver transplantation are scarce. In this RCT, Investigators aim to evaluate the effect of dapagliflozin vs sitagliptin on liver fat accumulation; body composition variables; and safety and efficacy of these oral hypoglycemic agents in patients with diabetes and liver transplantation

NCT ID: NCT04901169 Recruiting - Clinical trials for Liver Transplant; Complications

Angiotensin II in Liver Transplantation

AngLT-1
Start date: June 28, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of Angiotensin II as a second-line vasopressor (drug that raises the blood pressure) during liver transplantation.

NCT ID: NCT04867720 Recruiting - Liver Transplant Clinical Trials

Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients

STELLA
Start date: March 16, 2021
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus

NCT ID: NCT04836923 Recruiting - Frailty Clinical Trials

LIFT Intervention in Liver Transplant Candidates

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Frailty is a significant problem in patients undergoing liver transplant and is associated with poor outcomes and survival. Hence, optimizing physical fitness and counteracting frailty is important. However, many interventions are very resource intensive and therefore not feasible. In this study, the investigators aim to test the effectiveness of a newly designed intervention to improve frailty in liver transplant candidates. The "LIver FrailTy" intervention (LIFT) will consist of an evaluation by a physical therapist, an individualized home exercise prescription (HEP), exercise tracking using a smart phone application, daily text reminders to exercise and recurrent telephone check-ins. The investigators also aim to perform "Realistic Effort Action Planning" (REAP), which is a form of personality-informed motivational interviewing, in a subset of patients to determine if this enhances the LIFT intervention.

NCT ID: NCT04792801 Recruiting - Clinical trials for Hepatocellular Carcinoma

PET TDM FDG-Choline as a Decision-making Tool for Routine Care on the Liver Transplant List for HCC

TEP CARE
Start date: June 22, 2021
Phase:
Study type: Observational

HCC is the most common malignant liver tumor for which liver transplantation is one of the pivotal curative treatments. The best possible selection of patients who are candidates for transplantation is essential in the current context of a shortage of transplants. Performing a PET CT scan is not currently recommended in the pre-liver transplant workup for HCC. However, PET CT using in a complementary manner the FDG and Choline tracers appears promising in the management of HCC in view of its wide use in oncology and its major diagnostic and prognostic contribution compared to conventional imaging. In order to address this issue, a prospective cohort study including patients from the University Hospital of Rouen and Lille with hepatocellular carcinoma meeting the criteria for indication of liver transplantation validated in SPC will be set up, the main objective of which will be to assess the decision-making contribution of PET TDM FDG and Choline in addition to conventional imaging in the pre-transplant assessment.

NCT ID: NCT04762550 Recruiting - Clinical trials for Liver Transplantation

Thrombin Generation in Liver Transplant Surgery

Start date: March 8, 2021
Phase:
Study type: Observational

This is a prospective observational study of 100 patients undergoing liver transplantation at a single centre. Thrombin generation and kinetics will be assessed using a novel point-of-care device, and compared to conventional measures of hemostasis as well as viscoelastic tests to pinpoint specific coagulation deficits and identify potential therapeutic targets. The clinical course of patients will be followed for major bleeding and transfusion outcomes.