Complications of Pediatric Liver Transplantation

Early and Late Complications of Living Related Pediatric Liver Transplantation

Liver transplant is the treatment of choice in children with end-stage liver failure.liver transplant is indicated when the risk of mortality from the native liver disease outweighs the overall risk of transplantation.The complications occur both immediately post-transplantation and in the long-term. The main complications in the immediate postoperative period are related to the function of the graft (dysfunction and rejection), the surgical technique, infections (bacterial, fungal, and viral),and systemic problems (pulmonary, renal, or neurological) and in the long term, the complications are typically a consequence of the prolonged immunosuppressive therapy.

Study Overview

• Status: Unknown
• Conditions: Liver Transplant; Complications
• Intervention / Treatment: Diagnostic test: blood tests , abdominal US and doppler

Detailed Description

Liver transplant is the treatment of choice in children with end-stage liver failure. It involves the surgical removal of the entire organ, which is then replaced with a healthy donor liver. Having a healthy liver is essential to longevity because the liver is responsible for nutrient distribution and toxin removal in the body .

Living-donor liver transplantation has been developed to address the disparity between the number candidates for transplant and the reduced number of available organs for liver transplantation.

In general, liver transplant (LT) is indicated when the risk of mortality from the native liver disease outweighs the overall risk of transplantation. Indications for liver transplantation in children include malignant and non-malignant conditions.

The complications occur both immediately post-transplantation and in the long-term. The main complications in the immediate postoperative period are related to the function of the graft (dysfunction and rejection), the surgical technique, infections (bacterial, fungal, and viral),and systemic problems (pulmonary, renal, or neurological) and In the long term, the complications are typically a consequence of the prolonged immunosuppressive therapy.

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Ahmed MN Mohamed, MD; Phone Number: 02 01066778077; Email: elhomosany2020@yahoo.com
• Study Contact Backup: Name: Enas M Sayed, MD; Phone Number: 02 01004870406; Email: enasmhmd05@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut university children hospital
    • Contact: Ahmed MN Mohamed, MD; Phone Number: 02 01066778077; Email: elhomosany2020@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

children who were prepared for liver transplantation and followed up at Yassin Abdel Ghaffar charity center for liver disease and research,Cairo,Egypt.

Description

Inclusion Criteria:

• All patients from (1- 18) years old who were prepared for liver transplantation and followed up at Yassin Abdel Ghaffar charity center for liver disease and research,Cairo,Egypt. from January 2015 to the end of March 2020.

Exclusion Criteria:

• Any patient who did not survive beyond the first post operative day.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
with complications; children who did liver transplantation and develop complications	Diagnostic test: blood tests , abdominal US and doppler
without complications; children who did liver transplantation and do not develop complications	Diagnostic test: blood tests , abdominal US and doppler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hematological ,vascular and infectious complications	Number of patients have vascular complications Number of patients have pancytopenia Number of patients have bacterial viral or fungal infection any changes in septic screen of the patient	5 years

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Naglaa HI Abu.Faddan, prof, Assiut university children hospital

Publications and helpful links

General Publications

• Reuben A. Long-term management of the liver transplant patient: diabetes, hyperlipidemia, and obesity. Liver Transpl 2001; 7(Suppl 1): S13-21. Bucuvalas, J., Long-term outcomes in pediatric liver transplantation. Liver Transpl, 2009. 15Suppl 2: p. S6-11. Seyfert-Margolis, V. and S. Feng, Tolerance: is it achievable in pediatric solid organ transplantation? Pediatr Clin North Am, 2010. 57(2): p. 523-38, table of contents. Hackl, C., et al., Current developments in pediatric liver transplantation. World J Hepatol, 2015.7(11): p. 1509-20.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 28, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: liver transplantation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: there is a plan to make IPD and related data dictionaries available
• IPD Sharing Time Frame: starting at march 2020
• IPD Sharing Access Criteria: through finding the research in the site of ClinicalTrials.gov
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No