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The addition of Simvastatin administration to cold storage solution of explanted whole liver grafts for facing ischemia/reperfusion injury in an area with a low rate of deceased donation: a monocentric randomized controlled double-blinded phase 2 study
Universita degli Studi di Palermo
Department for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, IRCCS-ISMETT Via Ernesto Tricomi, 5, 90127 Palermo PA, Italy
Dr. Duilio Pagano
Dr. Duilio Pagano
Type of Research Project
- Clinical Project with Laboratory work
What is the background of the project?
Liver transplantation (LT) is the best treatment for end-stage liver disease. The interruption of the blood supply to the donor liver during cold storage damages the liver, affecting how well the liver will function after transplant. The drug Simvastatin may help to protect donor livers against this damage and improve outcomes for transplant recipients. This trial is designed to confirm the effectiveness of Simvastatin to protect healthy and steatotic livers undergoing cold storage and warm reperfusion before transplantation and to evaluate if the addition of Simvastatin translates into improved graft outcomes.
What is the aim of the project?
The aim of this study is to evaluate the benefits of treating the donor liver with Simvastatin compared with the standard transplant procedure.
What techniques and methods are used?
We propose a prospective, double-blinded, randomized phase 2 study of 2 parallel groups of eligible adult patients. We will compare 3-month, 6-month, and 12-month graft survival after LT, in order to identify a significant relation between the two homogenous groups of LT patients. The two groups only differ by the Simvastatin or placebo administration regimen while following the same procedure, with identical surgical instruments, and medical and nursing skilled staff. To reach these goals, we determined that we needed to recruit 106 patients. This sample size achieves 90% power to detect a difference of 14.6% between the two groups survival using a onesided binomial test.
What is the role of the student?
- The student will mainly observe
- The student will observe the practical experiments but will be highly involved in the analysis of the results
- If the project includes “lab work”
- the student will take active part in the practical aspect of the project
- If the project is clinical
- the student will take active part in the clinical examination
- If the project is clinical
- the student will be allowed to work with patients
- The tasks will be done under supervision
What are the tasks expected to be accomplished by the student?
The student will follow transplant patients both during the transplant and the follow up. He/she will assist the doctors during physical evaluations and medical history, and will be able to take part as a spectator during liver transplant operations. In addition, the student will be able to take part in post-operative statistical evaluations. By the end of the experience, he/she will have de-veloped statistical skills, being able to independently evaluate the results of the phase 2 study and to compare the differences in the out-comes of both patient groups.
Will there be any theoretical teaching provided (preliminary readings, lectures, courses, seminars etc)
We will provide some preliminary readings concerning the abstract before the research project starts. Our doctors will involve the students in every step of the project, giving them theoretical and practical knowledge.
What is expected from the student at the end of the research exchange? What will be the general outcome of the student?
- No specific outcome is expected
What skills are required of the student? Is there any special knowledge or a certain level of studies needed?
Are there any legal limitations in the student’s involvement
Type of students accepted
This project accepts: - Medical students - Graduated students (less than 6 months)
- Pagano D; Oliva E; Khouzam S; Tuzzolino F; Cintorino D; Li Petri S; di Francesco F; Ricotta C; Bonsignore P; Tropea A; Calamia S; Costanzo F; Luca A; Gruttadauria S. The addition of simvastatin administration to cold storage solution of explanted whole liver grafts for facing ischemia/reperfusion injury in an area with a low rate of deceased donation: a monocentric randomized controlled double-blinded phase 2 study. BMC Surg. 2018 Dec 27;18(1):122.
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